The following data is part of a premarket notification filed by G.d. Searle And Co. with the FDA for Ecg Amplifier/r Wave Trigger.
| Device ID | K771976 |
| 510k Number | K771976 |
| Device Name: | ECG AMPLIFIER/R WAVE TRIGGER |
| Classification | Amplifier And Signal Conditioner, Biopotential |
| Applicant | G.D. SEARLE AND CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DRR |
| CFR Regulation Number | 870.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-10-17 |
| Decision Date | 1977-11-09 |