FDA 510(k)

ECG TELEMETRY SYSTEM

K-Number: K772000 · 1977-11-22

Decision Date1977-11-22

Product CodeDRG

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ECG TELEMETRY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mennen Greatbatch Electonics. It received FDA 510(k) clearance on 1977-11-22 under 510(k) number K772000. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECG TELEMETRY SYSTEM?

ECG TELEMETRY SYSTEM is a medical device that received FDA 510(k) clearance on 1977-11-22. The listed applicant is Mennen Greatbatch Electonics. The 510(k) number is K772000.

When did ECG TELEMETRY SYSTEM receive FDA 510(k) clearance?

ECG TELEMETRY SYSTEM received FDA 510(k) clearance on 1977-11-22, under 510(k) number K772000.

Who is the listed applicant for ECG TELEMETRY SYSTEM?

The FDA 510(k) record lists Mennen Greatbatch Electonics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECG TELEMETRY SYSTEM?

The FDA product code for ECG TELEMETRY SYSTEM is DRG.

Related Clinical Trials

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Other records listing Mennen Greatbatch Electonics as applicant

K770832PORTASCOPE II K770279MONITOR, PORTABLE, PART #431-010 K770247D.C. AMPLIFIER MODULE K770246ISOLATED EEG AMPLIFIER MODULE K770245ABDOMINAL FETAL ECG MODULE

Related Devices (Code: DRG)

K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.K250259TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare Corporation K243837iBSMIorbit Digital Technologies Private Limited K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.

Official Source

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