MODEL600 UTERINE ACTIVITY MONITOR
FDA 510(k) clearance K903623 · decided 1990-11-07
Clearance details
- K-number
- K903623
- Device name
- MODEL600 UTERINE ACTIVITY MONITOR
- Applicant
- Corometrics Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-08-09
- Decision date
- 1990-11-07
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- HFM
- Device class
- 2
- Regulation number
- 884.2720
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Wallingford, CT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| KOALA TOCO (K140163) | Clinical Innovations, LLC | 2014-05-29 |
| FEATHERLITE AQUA TOCODYNAMOMETER (K061044) | Ventrex, Inc. | 2006-07-12 |
| TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING (K040392) | American I.V. Products, Inc. | 2004-09-14 |
| TOCO LITE, MODEL TD-01 (K013477) | Ventrex, Inc. | 2002-01-17 |
| SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565 (K994353) | Precision Dynamics Corp. | 2000-03-22 |
| TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING (K992811) | Epic Medical Equipment Services, Inc. | 2000-01-18 |
| DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES (K954847) | Ocg Systems, Inc. | 1996-05-22 |
| TOCO TRANSDUCER (K952579) | Scientific Device Manufacturer, LLC | 1995-08-04 |
| BUBBLE TOCO (K920152) | Utah Medical Products, Inc. | 1993-05-26 |
| MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER (K910282) | Graphic Controls Corp. | 1991-03-29 |
| AIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYST (K904691) | Air-Shields Vickers, Inc. | 1991-02-19 |
| ORION WATCHGUARD (K902104) | Orion Industries | 1990-10-25 |
Recalls involving this device
No recalls on record reference this clearance.