Monitor, Blood-Flow, Ultrasonic
The Ultrasonic Blood-Flow Monitor is a device that uses Doppler ultrasound to detect and assess blood flow in obstetric or gynecological applications, providing non-invasive hemodynamic information during pregnancy or clinical procedures. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HEP, regulated under 21 CFR 884.2660, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.
Research product code HEP in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- HEP
- Device Class
- FDA class 2
- Regulation Number
- 884.2660
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K101960 | SONOTRAX SERIES ULTRASONIC POCKET DOPPLER | Aug 10, 2010 | Substantially Equivalent | Edan Instruments, Inc. |
| K023082 | BABYCARE | Mar 03, 2003 | Substantially Equivalent | Bionet Company, Ltd. |
| K920353 | ULTRACELL INSTRUMENT WIPE | Sep 15, 1992 | Substantially Equivalent | Ultracell Medical Technologies, Inc. |
| K910462 | POCKET DOP 3 | Jun 24, 1991 | Substantially Equivalent | Imex Medical Systems, Inc. |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.