Fetal Monitor Model FHM-1
by Advantage Medical Systems, Inc.
510(k) K800013
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK800013 | Date7 Mar 1980 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HGM
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.2740
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The Fetal Monitor Model FHM-1 is a perinatal monitoring system designed for clinical use. It functions to track and record fetal physiological data to assist in monitoring during the perinatal period.
This device is identified by FDA 510(k) clearance number K800013. It is classified as a Class 2 medical device under regulation number 884.2740.
Other devices from Advantage Medical Systems, Inc.
Questions
AI-generated answers, 21 Sep 2026
What is the primary function of the Fetal Monitor Model FHM-1?
The FHM-1 is a perinatal monitoring system designed for clinical use. Its primary function is to track and record fetal physiological data to assist healthcare providers in monitoring patients during the perinatal period.
What is the regulatory status of this device?
The Fetal Monitor Model FHM-1 has received FDA 510(k) clearance under number K800013. It is classified as a Class 2 medical device under regulation number 884.2740.
Which medical specialty is this monitor intended for?
This device is intended for use within the field of Obstetrics and Gynecology, as indicated by its classification under the OB advisory committee.