FDA Product Code
FDA Product Code LHC — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.5950
510(k) Clearances — 24 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K153713 | Getinge Series Warming Cabinet | Getinge Sourcing, LLC | 2016-06-07 | Traditional | PDF ↗ |
| K152522 | ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes | Ecolab, Inc. | 2016-01-15 | Special | PDF ↗ |
| K150190 | IntraTemp Solution Warmer | Ecolab, Inc. | 2015-02-26 | Special | PDF ↗ |
| K142173 | NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE | Ecolab, Inc. | 2014-12-30 | Traditional | PDF ↗ |
| K142080 | NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED | Ecolab, Inc. | 2014-08-28 | Special | PDF ↗ |
| K083417 | INTRATEMP SOLUTION WARMER | C Change Surgical, LLC | 2009-01-13 | Traditional | PDF ↗ |
| K080609 | SWC/DWC WARMING CABINETS | Mac Medical | 2008-06-13 | Traditional | PDF ↗ |
| K051819 | C CHANGE SOLUTION WARMER | C Change Surgical, LLC | 2005-08-15 | Traditional | PDF ↗ |
| K023282 | ORS-3000LD | O.R. Solutions, Inc. | 2002-11-13 | Traditional | PDF ↗ |
| K023283 | 1075LD HUSH-SLUSH | O.R. Solutions, Inc. | 2002-11-13 | Traditional | PDF ↗ |
| K021288 | ORS-1000LD | O.R. Solutions, Inc. | 2002-06-27 | Traditional | PDF ↗ |
| K021289 | WARMER 2000LD | O.R. Solutions, Inc. | 2002-06-26 | Traditional | PDF ↗ |
| K002859 | SSW-STERILE SOLUTION WARMER | Kmi Kolster Methods, Inc. | 2000-11-16 | Traditional | PDF ↗ |
| K965136 | UROSURGE UROTHERM FLUID WARMING SYSTEM | Princeton Regulatory Assoc. | 1998-10-16 | Traditional | PDF ↗ |
| K971117 | WARMETTE | Olympic Medical Corp. | 1997-08-22 | Traditional | PDF ↗ |
| K951300 | NEZHAT-DORSEY THERMAL RETENTION SYSTEM | American Hydro-Surgical Instruments, Inc. | 1995-06-20 | Traditional | PDF ↗ |
| K932538 | CABOT MEDICAL IRRIGATION FLUID WARMER SETS | Cabot Medical Corp. | 1994-02-22 | Traditional | PDF ↗ |
| K933726 | MODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEM | Augustine Medical, Inc. | 1994-01-28 | Traditional | PDF ↗ |
| K921633 | ORS-2000 SERIES | Mnlase, Inc. | 1992-06-02 | Traditional | PDF ↗ |
| K880876 | C-STAT/1000 | Sonne Medical, Inc. | 1988-05-20 | Traditional | PDF ↗ |
| K880252 | THERMAL-PAK MODEL SW 1000 | Micro Tek Engineering | 1988-02-10 | Traditional | PDF ↗ |
| K833944 | STERILE SOLUTION WARMER | National Fabtronix, Inc. | 1984-01-25 | Traditional | PDF ↗ |
| K832642 | ALPHA-I | Johnson Flexgroup | 1983-11-21 | Traditional | PDF ↗ |
| K811524 | AQUACADE | Respiratory Care, Inc. | 1981-07-01 | Traditional | PDF ↗ |
Product code LHC · Class I · Physical Medicine. Data: openFDA.