FDA Product Code
FDA Product Code DWJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.5900
510(k) Clearances — 161 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K003349 | ALLON 2001 MODIFIED | Mtre Advanced Technology , Ltd. | 2000-11-13 | Special | PDF ↗ |
| K002577 | ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL UNIT AND PATIENT ENERGY TRANSFER PADS | Medivance, Inc. | 2000-10-26 | Traditional | PDF ↗ |
| K001149 | AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANK | Augustine Medical, Inc. | 2000-09-06 | Traditional | PDF ↗ |
| K001546 | ALLON 2001 | Mtre Advanced Technology , Ltd. | 2000-06-08 | Special | PDF ↗ |
| K981093 | WESCO BLANKET | Wesco, Inc. | 2000-03-28 | Traditional | PDF ↗ |
| K992386 | ALLON 2000 | Mtre Advanced Technology , Ltd. | 2000-03-07 | Traditional | PDF ↗ |
| K991684 | CHILLBUSTER PORTABLE ELECTRIC BLANKET SYSTEM, MODEL 8001 | Thermogear, Inc. | 2000-03-01 | Traditional | PDF ↗ |
| K973705 | CONTOR TABLE SURFACE | Hill-Rom, Inc. | 1998-08-07 | Traditional | PDF ↗ |
| K970367 | THERMO-STAT SYSTEM | Aquarius Medical Corp. | 1997-12-17 | Traditional | PDF ↗ |
| K964673 | BAIR HUGGER MODEL 630 CARDIAC BLANKET | Augustine Medical, Inc. | 1997-06-26 | Traditional | PDF ↗ |
| K964377 | THERMAL REGULATION SYSTEM BLANKET | Gibeck, Inc. | 1997-04-23 | Traditional | PDF ↗ |
| K963731 | TRU-5000 THERMAL RECOVERY RADIANT HEATING UNIT | Enthermics Medical Systems, Inc. | 1997-04-22 | Traditional | PDF ↗ |
| K960511 | GIBECK WARMBAG REUSABLE CONVECTIVE WARMING BLANKET | Gibeck, Inc. | 1997-01-13 | Traditional | PDF ↗ |
| K960167 | SYSTEM, THERMAL REGULATING 74-DWJ | Augustine Medical, Inc. | 1996-06-17 | Traditional | PDF ↗ |
| K952329 | LIFE-AIR 1000 HYPOTHERMIC THERAPY SYSTEM | Progressive Dynamics, Inc. | 1996-01-17 | Traditional | PDF ↗ |
| K952864 | BAIR HUGGER MODEL 655 BLANKET | Augustine Medical, Inc. | 1995-09-12 | Traditional | PDF ↗ |
| K952086 | TROPICAIR CONVECTIVE WARMING BLANKETS | Seabrook Medical Systems, Inc. | 1995-09-06 | Traditional | PDF ↗ |
| K946196 | TROPICAIR CONVECTIVE WARING SYSTEM | Seabrook Medical Systems, Inc. | 1995-09-06 | Traditional | PDF ↗ |
| K950416 | BAIR HUGGER MODEL 600 UNIT, BLANKETS | Augustine Medical, Inc. | 1995-08-29 | Traditional | PDF ↗ |
| K942881 | TC 3000 | Gaymar Industries, Inc. | 1995-05-23 | Traditional | PDF ↗ |
| K942599 | WARM AIR WARMING UNIT | Cincinnati Sub-Zero Products, Inc. | 1995-01-24 | Traditional | PDF ↗ |
| K942790 | WARM AIR HYPERTHEERMIA SYSTEM (MODELS #130 AND #133) | Cincinnati Sub-Zero Products, Inc. | 1995-01-24 | Traditional | PDF ↗ |
| K943276 | WARMTOUCH PLASTIC WARMING COVER | Mallinckrodt Medical | 1994-09-19 | Traditional | PDF ↗ |
| K940171 | CABOT MEDICAL NIAGRA-TRS THERMAL RETENTION SYSTEM | Cabot Medical Corp. | 1994-03-09 | Traditional | PDF ↗ |
| K933764 | LIFE-AIR 1000 PATIENT WARMING COVER | Progressive Dynamics, Inc. | 1993-11-09 | Traditional | PDF ↗ |
| K930345 | TC2000 POWER UNIT AND ACCESSORIES | Gaymar Industries, Inc. | 1993-08-06 | Traditional | PDF ↗ |
| K923104 | TROPIC-AIR | Seabrook Medical Systems, Inc. | 1993-07-13 | Traditional | PDF ↗ |
| K921920 | SOFT-TEMP | Adroit Medical Systems, Inc. | 1992-12-11 | Traditional | PDF ↗ |
| K921165 | BAIR HUGGER TORSO BLANKET - ARMS IN MODEL 540 | Augustine Medical, Inc. | 1992-08-06 | Traditional | PDF ↗ |
| K920432 | BAIR HUGGER CUB BLANKET- SHORT MODEL 536 | Augustine Medical, Inc. | 1992-06-18 | Traditional | PDF ↗ |
| K914382 | LIFE-AIR 1000 HYPOTHERMIC TREATMENT SYSTEM | Progressive Dynamics, Inc. | 1992-04-21 | Traditional | PDF ↗ |
| K914383 | LIFE-AIR 1000 PATIENT WARMING COVERS | Progressive Dynamics, Inc. | 1992-03-30 | Traditional | PDF ↗ |
| K920265 | BAIR HUGGER PATIENT WARMING SYSTEM | Augustine Medical, Inc. | 1992-03-27 | Traditional | PDF ↗ |
| K914805 | TC-1000, TC-1050 SYSTEM | Gaymar Industries, Inc. | 1992-01-07 | Traditional | PDF ↗ |
| K913734 | BAIR HUGGER(R) PATIENT WARM SYST/BABY WARM COVER | Augustine Medical, Inc. | 1991-10-23 | Traditional | PDF ↗ |
| K913016 | WARMTOUCH | Advanced Warming Systems, Inc. | 1991-09-04 | Traditional | PDF ↗ |
| K912051 | MEDI-THERM (MTA-5900) & DETACHABLE HOSES | Gaymar Industries, Inc. | 1991-07-30 | Traditional | PDF ↗ |
| K910327 | WARMAIR SYSTEM | Cincinnati Sub-Zero Products, Inc. | 1991-05-16 | Traditional | PDF ↗ |
| K904690 | TEMP MARQ(TM) CONVECTIVE WARMING SYSTEM | Marquest Medical Products, Inc. | 1991-02-01 | Traditional | PDF ↗ |
| K902650 | BODYHEAT | Medadvances, Inc. | 1990-12-20 | Traditional | PDF ↗ |
| K902756 | TROPI-COOL | Seabrook Medical Systems, Inc. | 1990-10-22 | Traditional | PDF ↗ |
| K903360 | BAIR HUGGER(R) PATIENT WARMING SYSTEM-MODIFICATION | Augustine Medical, Inc. | 1990-08-14 | Traditional | PDF ↗ |
| K900186 | BONCHEK-SHILEY CARDIAC JACKET W/RECIRCULATION SET | Shiley, Inc. | 1990-04-10 | Traditional | PDF ↗ |
| K894980 | BIO-CAL 370 HEATER/COOLER | Bio Medicus, Inc. | 1989-11-02 | Traditional | PDF ↗ |
| K890575 | ACCUTHERM PTS-200 | Medical Repackers Co. | 1989-05-05 | Traditional | PDF ↗ |
| K882442 | RK2000 K-THERMIA SYSTEM | Baxter Healthcare Corp | 1988-09-06 | Traditional | PDF ↗ |
| K882035 | HEART-CHILL SALINE SLUSH PAD | Buckman Co., Inc. | 1988-07-28 | Traditional | PDF ↗ |
| K881322 | MINI-TEMP(TM) | Seabrook Medical Systems, Inc. | 1988-06-22 | Traditional | PDF ↗ |
| K873546 | VES-TEMP MODEL VT1 MONOPLACE COOL/HEAT SYSTEM | Reimers Engineering, Inc. | 1988-01-29 | Traditional | PDF ↗ |
| K873745 | BAIR HUGGER(TM) - PATIENT WARMING SYSTEM | Augustine Medical, Inc. | 1987-11-06 | Traditional | PDF ↗ |
| K854856 | THERMORITE MODEL HC-83 HYPO/HYPERTHERMIA UNIT | Thermorite, Inc. | 1986-06-02 | Traditional | PDF ↗ |
| K820814 | THERMO-K | American Medical Systems, Inc. | 1982-04-29 | Traditional | PDF ↗ |
| K812955 | EAST WATER UNIT MARK 3 | Cairco , Ltd. | 1981-12-29 | Traditional | PDF ↗ |
| K811742 | HEMOTHERM MODEL 400 | Cincinnati Sub-Zero | 1981-08-13 | Traditional | PDF ↗ |
| K811743 | MAXITHERM | Cincinnati Sub-Zero | 1981-07-16 | Traditional | PDF ↗ |
| K801253 | CREST ELECTRONIC WARMING BLANKET | Penlon, Inc. | 1981-01-02 | Traditional | PDF ↗ |
| K800812 | MEDI-THERM | Gaymar Industries, Inc. | 1980-04-24 | Traditional | PDF ↗ |
| K772015 | PATIENT HEATER SYSTEM, MODEL PH112 | Carolina Medical Electronics | 1977-11-15 | Traditional | PDF ↗ |
| K771537 | AQUAMATIC K-MODULE MODEL K-20 | Gorman Rupp Industries | 1977-09-06 | Traditional | PDF ↗ |
| K770839 | AQUAMATIC K-77 | Gorman Rupp Industries | 1977-06-08 | Traditional | PDF ↗ |
| K761087 | ELECTRONIC CONTROL UNIT | Gorman Rupp Industries | 1976-12-06 | Traditional | PDF ↗ |
Product code DWJ · Class II · Cardiovascular. Data: openFDA.