510(k) K771976
K771976 is an FDA 510(k) premarket notification submitted by G.D. Searle And Co. for the device "ECG AMPLIFIER/R WAVE TRIGGER". The FDA issued a decision of Substantially Equivalent on Nov 9, 1977. The device falls under product code DRR (Amplifier And Signal Conditioner, Biopotential), a Class II device regulated under 21 CFR 870.2050. G.D. Searle And Co. has 55 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 9, 1977
- Date Received
- Oct 17, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Amplifier And Signal Conditioner, Biopotential
- Device Class
- Class II
- Regulation Number
- 870.2050
- Review Panel
- CV
- Submission Type
- 510(k)