MODEL600 Uterine Activity Monitor
FDA 510(k) K903623 · Corometrics Medical Systems, Inc.
510(k) numberK903623
Submission
- Device name
- MODEL600 Uterine Activity Monitor
- Applicant
- Corometrics Medical Systems, Inc.
Wallingford, CT, US - Received
- August 9, 1990
- Decision date
- November 7, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HFM – Monitor, Uterine Contraction, External (For Use In Clinic)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2720
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HFM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K140163 | Koala TocoHFM · Traditional | Clinical Innovations, LLC | 05/29/2014SE |
| K061044 | Featherlite Aqua TocodynamometerHFM · Traditional | Ventrex, Inc. | 07/12/2006SE |
| K040392 | Transducers for Ultrasound and Tocodynamometer Fetal MonitoringHFM · Traditional | American I.V. Products, Inc. | 09/14/2004SE |
| K013477 | Toco Lite, Model TD-01HFM · Traditional | Ventrex, Inc. | 01/17/2002SE |
| K994353 | Secureline Disposable Fetal Monitoring Straps #3860 and #3565HFM · Traditional | Precision Dynamics Corp. | 03/22/2000SE |
| K992811 | Transducers for Ultrasound and Tocodynamometer Fetal MonitoringHFM · Abbreviated | Epic Medical Equipment Services, Inc. | 01/18/2000SE |
| K954847 | Disco Uterine Contraction Transducer & AccessoriesHFM · Traditional | Ocg Systems, Inc. | 05/22/1996SE |
| K952579 | Toco TransducerHFM · Traditional | Scientific Device Manufacturer, LLC | 08/04/1995SE |
| K920152 | Bubble TocoHFM · Traditional | Utah Medical Products, Inc. | 05/26/1993SE |
| K910282 | Medi-Trace(R) Disposable TocotonometerHFM · Traditional | Graphic Controls Corp. | 03/29/1991SE |
More from Graphic Controls Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K982651 | Corometrics Model 5700 and 2264 Watertight TransducerHEL · Traditional | 12/11/1998SE |
| K905000 | Aloka UST-964P-5 Endovaginal TransducerHEM · Traditional | 01/31/1991SE |
| K891997 | Catalog #2270AAX, 2270DAX Beltless TocotransducerHFM · Traditional | 06/08/1989SE |
| K880900 | SSD-620 Linear/Convex Array Sector ScannerHEM · Traditional | 06/01/1988SE |
Questions and answers
When was MODEL600 Uterine Activity Monitor cleared by the FDA?
MODEL600 Uterine Activity Monitor (K903623) received a 510(k) decision of Substantially Equivalent on November 7, 1990, 90 days after the submission was received.
What is the product code of K903623?
The FDA product code is HFM – Monitor, Uterine Contraction, External (For Use In Clinic), a Class II (moderate risk) device regulated under 21 CFR 884.2720.