ECG TELEMETRY SYSTEM— 510(k) K772000

Name: FDA 510(k) clearance K772000
Creator: U.S. Food and Drug Administration
Published: 1977-11-22

Substantially Equivalent

Mennen Greatbatch Electonics

FDA 510(k) clearance K772000 for ECG TELEMETRY SYSTEM, Substantially Equivalent on 1977-11-22. Applicant: Mennen Greatbatch Electonics. Device class: 2.

Clearance details

Applicant: Mennen Greatbatch Electonics
Product code: Code DRG
Device class: Class 2
Regulation: 21 CFR 870.2910
Advisory panel: Cardiovascular
Date received: 1977-10-21
Decision date: 1977-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Mennen Greatbatch Electonics

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K770832 — PORTASCOPE II1977-06-03
K770279 — MONITOR, PORTABLE, PART #431-0101977-02-24
K770245 — ABDOMINAL FETAL ECG MODULE1977-02-14
K770246 — ISOLATED EEG AMPLIFIER MODULE1977-02-14
K770247 — D.C. AMPLIFIER MODULE1977-02-14

Adverse events under product code DRG

product code DRG

Death: 5
Total: 5

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.