Fetal Monitor, Part #101-11009
510(k) K770296
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK770296 | Date9 Mar 1977 | 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- Withdrawn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, 24 Sep 2026
A fetal monitor is a system used to show graphically the relationship between maternal labor and the fetal heart rate by combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of fetal well-being during pregnancy, labor, and delivery. This device, identified as Fetal Monitor, Part #101-11009, is a perinatal monitoring system classified under obstetrics/gynecology.
It was cleared by the FDA through the traditional 510(k) pathway under k-number K770296, with a decision date of March 9, 1977, and is classified as a Class II device under regulation 884.2740. The device is manufactured by Brattle Instrument Corp. and is intended for use in clinical settings for perinatal monitoring.
Other devices from Brattle Instrument Corp.
Questions
AI-generated answers, 24 Sep 2026
What is the Fetal Monitor, Part #101-11009 used for?
This device is used to graphically display the relationship between maternal uterine contractions and fetal heart rate during pregnancy, labor, and delivery to assess fetal well-being by combining and coordinating uterine and fetal heart monitoring with appropriate visual displays.
How was the Fetal Monitor, Part #101-11009 authorized for market release?
It was cleared by the FDA through the traditional 510(k) pathway under k-number K770296, with a decision date of March 9, 1977, based on a determination of substantial equivalence to a legally marketed predicate device.
What regulatory classification applies to the Fetal Monitor, Part #101-11009?
The device is classified as a Class II medical device under FDA regulation 884.2740, which pertains to perinatal monitoring systems, and was assigned product code HGM by the FDA.