510(k) K770296
K770296 is an FDA 510(k) premarket notification submitted by Brattle Instrument Corp. for the device "FETAL MONITOR, PART #101-11009". The FDA issued a decision of Substantially Equivalent on March 9, 1977. The device falls under product code HGM (System, Monitoring, Perinatal), a Class II device regulated under 21 CFR 884.2740. Brattle Instrument Corp. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 9, 1977
- Date Received
- February 14, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Monitoring, Perinatal
- Device Class
- Class II
- Regulation Number
- 884.2740
- Review Panel
- OB
- Submission Type