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FDA 510(k)

ECG AMPLIFIER/R WAVE TRIGGER

K-Number: K771976 · 1977-11-09

ApplicantG.D. Searle and Co.
Decision Date1977-11-09
Product CodeDRR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECG AMPLIFIER/R WAVE TRIGGER is the device name listed in this FDA 510(k) record. The listed applicant is G.D. Searle and Co.. It received FDA 510(k) clearance on 1977-11-09 under 510(k) number K771976. The device is classified under product code DRR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECG AMPLIFIER/R WAVE TRIGGER?

ECG AMPLIFIER/R WAVE TRIGGER is a medical device that received FDA 510(k) clearance on 1977-11-09. The listed applicant is G.D. Searle and Co.. The 510(k) number is K771976.

When did ECG AMPLIFIER/R WAVE TRIGGER receive FDA 510(k) clearance?

ECG AMPLIFIER/R WAVE TRIGGER received FDA 510(k) clearance on 1977-11-09, under 510(k) number K771976.

Who is the listed applicant for ECG AMPLIFIER/R WAVE TRIGGER?

The FDA 510(k) record lists G.D. Searle and Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECG AMPLIFIER/R WAVE TRIGGER?

The FDA product code for ECG AMPLIFIER/R WAVE TRIGGER is DRR.

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Other records listing G.D. Searle and Co. as applicant

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Related Devices (Code: DRR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K022660BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117Biocheck, Inc.K971570EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391Quinton Electrophysiology Corp.K925346EP AMP, MODEL #901Quinton Electrophysiology Corp.K914381HORIZON 9000/HIS OPTION AMPLIFIERMennen Medical, Inc.K911935CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIEDGould, Inc.K910307CARDIOLAB AMPLIFIER MODULE (CAM)Prucka Engineering, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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