510(k) K761139
K761139 is an FDA 510(k) premarket notification submitted by G.D. Searle And Co. for the device "T-M (TIME-MOTION) OPTION". The FDA issued a decision of Substantially Equivalent on Dec 16, 1976. The device falls under product code HGM (System, Monitoring, Perinatal), a Class II device regulated under 21 CFR 884.2740. G.D. Searle And Co. has 55 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 16, 1976
- Date Received
- Nov 26, 1976
- 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
- 510(k)