ECG Amplifier/R Wave Trigger
FDA 510(k) K771976 · G.D. Searle and Co.
510(k) numberK771976
Submission
- Device name
- ECG Amplifier/R Wave Trigger
- Applicant
- G.D. Searle and Co.
Mchenry, IL, US - Received
- October 17, 1977
- Decision date
- November 9, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRR – Amplifier And Signal Conditioner, Biopotential
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2050
- Specialty
- Cardiovascular
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| K971570 | Epxpress System (Timberwolf Revision) /000391DRR · Traditional | Quinton Electrophysiology Corp. | 12/29/1997SE |
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| K914381 | Horizon 9000/HIS Option AmplifierDRR · Traditional | Mennen Medical, Inc. | 01/28/1992SE |
| K911935 | Cardiac Electrophysical Lead Selector, ModifiedDRR · Traditional | Gould, Inc. | 07/22/1991SE |
| K910307 | Cardiolab Amplifier Module (Cam)DRR · Traditional | Prucka Engineering, Inc. | 04/12/1991SE |
| K894735 | ASC-952 Physiological AmplifierDRR · Traditional | Astro-Med, Inc. | 09/18/1989SE |
| K894161 | ASC-950 ECG AmplifierDRR · Traditional | Astro-Med, Inc. | 08/03/1989SE |
| K874441 | Bard Biopotential AmplifierDRR · Traditional | C.R. Bard, Inc. | 01/19/1988SE |
| K853652 | BERS-400A Electrophysiological Amplifiers & InputDRR · Traditional | Fisher Imaging Corp. | 01/16/1986SE |
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| K803238 | Intravascular CatheterFOZ · Traditional | 04/23/1981SE |
| K810630 | Silicone Elastomer Coated Latex FoleyKOD · Traditional | 03/31/1981SE |
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| K802485 | Searle Vascular LoopsKDC · Traditional | 02/12/1981SE |
| K801805 | Metronidazole DiscsJWY · Traditional | 02/10/1981SE |
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Questions and answers
When was ECG Amplifier/R Wave Trigger cleared by the FDA?
ECG Amplifier/R Wave Trigger (K771976) received a 510(k) decision of Substantially Equivalent on November 9, 1977, 23 days after the submission was received.
What is the product code of K771976?
The FDA product code is DRR – Amplifier And Signal Conditioner, Biopotential, a Class II (moderate risk) device regulated under 21 CFR 870.2050.