510(k) K992811
- Device
- TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
- Applicant
- EPIC MEDICAL EQUIPMENT SERVICES, INC.
- 510(k) number
- K992811
- Product code
- HFM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-01-18
- Date received
- 1999-08-20
- Regulation
- 884.2720
- Classification name
- Monitor, Uterine Contraction, External (for Use In Clinic)
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KRISTA OAKES
- Address
- 1800 10th St., Suite 300 Plano TX US 75074 75074
FDA Registration Numbers#
- 9681377
- 3012528160
- 3014541700
- 3007734888
- 3013783488
- 3000126629
- 3003971136
- 1121996
- 1218950
- 9617277
- 3016701404
- 9610816
- 3003450039
- 3009077524
- 1722684
Source Documents#
Other 510(k) Records For Product Code HFM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K140163 | KOALA TOCO | Clinical Innovations, LLC | 2014-05-29 |
| K061044 | FEATHERLITE AQUA TOCODYNAMOMETER | Ventrex, Inc. | 2006-07-12 |
| K040392 | TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING | American I.V. Products, Inc. | 2004-09-14 |
| K994353 | SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565 | Precision Dynamics Corp. | 2000-03-22 |
| K954847 | DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES | Ocg Systems, Inc. | 1996-05-22 |
| K952579 | TOCO TRANSDUCER | Scientific Device Manufacturer, LLC | 1995-08-04 |
| K920152 | BUBBLE TOCO | Utah Medical Products, Inc. | 1993-05-26 |
| K910282 | MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER | Graphic Controls Corp. | 1991-03-29 |
| K904691 | AIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYST | Air-Shields Vickers, Inc. | 1991-02-19 |
| K903623 | MODEL600 UTERINE ACTIVITY MONITOR | Corometrics Medical Systems, Inc. | 1990-11-07 |
| K902104 | ORION WATCHGUARD | Orion Industries | 1990-10-25 |
| K894030 | MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR | Healthdyne, Inc. | 1990-01-22 |
| K893770 | TERM GUARD II DEVICE | Tokos Medical Corp. | 1989-11-03 |
| K891997 | CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCER | Corometrics Medical Systems, Inc. | 1989-06-08 |
| K882080 | MODEL NUMBER (TBD) TOCO DATA TELEPHONE TRANS. SYS. | Aequitron Medical, Inc. | 1989-03-01 |
Legacy Summary#
summary
FDA Review#
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