CARD GUARD-3000 ECG TELEPHONE ADAPTER— 510(k) K910450

Name: FDA 510(k) clearance K910450
Creator: U.S. Food and Drug Administration
Published: 1991-05-07

Substantially Equivalent

Medtech Industries, Inc.

FDA 510(k) clearance K910450 for CARD GUARD-3000 ECG TELEPHONE ADAPTER, Substantially Equivalent on 1991-05-07. Applicant: Medtech Industries, Inc.. Device class: 2.

Clearance details

Applicant: Medtech Industries, Inc.
Product code: Code DXH
Device class: Class 2
Regulation: 21 CFR 870.2920
Advisory panel: Cardiovascular
Date received: 1991-02-01
Decision date: 1991-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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