AEROTEL TELELINK ECG TELEPHONIC RECEIVING INTERFACE— 510(k) K961362

Name: FDA 510(k) clearance K961362
Creator: U.S. Food and Drug Administration
Published: 1996-07-10

Substantially Equivalent

Aerotel, Ltd.

FDA 510(k) clearance K961362 for AEROTEL TELELINK ECG TELEPHONIC RECEIVING INTERFACE, Substantially Equivalent on 1996-07-10. Applicant: Aerotel, Ltd.. Device class: 2.

Clearance details

Applicant: Aerotel, Ltd.
Product code: Code DXH
Device class: Class 2
Regulation: 21 CFR 870.2920
Advisory panel: Cardiovascular
Date received: 1996-04-09
Decision date: 1996-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rutherford, NJ, US

Download summary PDF View on FDA.gov ↗

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