FDA Product Code
FDA Product Code HFM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.2720
510(k) Clearances — 23 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K140163 | KOALA TOCO | Clinical Innovations, LLC | 2014-05-29 | Traditional | PDF ↗ |
| K061044 | FEATHERLITE AQUA TOCODYNAMOMETER | Ventrex, Inc. | 2006-07-12 | Traditional | PDF ↗ |
| K040392 | TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING | American I.V. Products, Inc. | 2004-09-14 | Traditional | PDF ↗ |
| K013477 | TOCO LITE, MODEL TD-01 | Ventrex, Inc. | 2002-01-17 | Traditional | PDF ↗ |
| K994353 | SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565 | Precision Dynamics Corp. | 2000-03-22 | Traditional | PDF ↗ |
| K992811 | TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING | Epic Medical Equipment Services, Inc. | 2000-01-18 | Abbreviated | PDF ↗ |
| K954847 | DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES | Ocg Systems, Inc. | 1996-05-22 | Traditional | PDF ↗ |
| K952579 | TOCO TRANSDUCER | Scientific Device Manufacturer, LLC | 1995-08-04 | Traditional | PDF ↗ |
| K920152 | BUBBLE TOCO | Utah Medical Products, Inc. | 1993-05-26 | Traditional | PDF ↗ |
| K910282 | MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER | Graphic Controls Corp. | 1991-03-29 | Traditional | PDF ↗ |
| K904691 | AIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYST | Air-Shields Vickers, Inc. | 1991-02-19 | Traditional | PDF ↗ |
| K903623 | MODEL600 UTERINE ACTIVITY MONITOR | Corometrics Medical Systems, Inc. | 1990-11-07 | Traditional | PDF ↗ |
| K902104 | ORION WATCHGUARD | Orion Industries | 1990-10-25 | Traditional | PDF ↗ |
| K894030 | MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR | Healthdyne, Inc. | 1990-01-22 | Traditional | PDF ↗ |
| K893770 | TERM GUARD II DEVICE | Tokos Medical Corp. | 1989-11-03 | Traditional | PDF ↗ |
| K891997 | CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCER | Corometrics Medical Systems, Inc. | 1989-06-08 | Traditional | PDF ↗ |
| K882080 | MODEL NUMBER (TBD) TOCO DATA TELEPHONE TRANS. SYS. | Aequitron Medical, Inc. | 1989-03-01 | Traditional | PDF ↗ |
| K873150 | PDS, MODEL NST 40 FETAL MONITOR, RECORDER & TRANS. | Pediatric Diagnostic Service | 1988-03-11 | Traditional | PDF ↗ |
| K874631 | HEALTHPHONE TOCO MODEL | Carelink | 1988-03-11 | Traditional | PDF ↗ |
| K860933 | AIR-CUSHION TOCOTONOMETER | International Biomedics, Inc. | 1986-07-09 | Traditional | PDF ↗ |
| K853856 | EXTERNAL UTERINE CONTRACTION MONITOR-TOKODYNAMOMET | Aequitron Medical, Inc. | 1986-03-12 | Traditional | PDF ↗ |
| K843011 | TERM GUARD 5000 UTERINE ACTIVITY | Tokos Medical Corp. | 1984-11-01 | Traditional | PDF ↗ |
| K840747 | TOCO DATA TELEPHONE TRANSMITTER DT100P | Advantage Medical Systems, Inc. | 1984-06-19 | Traditional | PDF ↗ |
Product code HFM · Class II · Obstetrics/Gynecology. Data: openFDA.