HEARTLINE TRANSTELEPHONIC ECG RECEIVING CONSOLE— 510(k) K930314

Name: FDA 510(k) clearance K930314
Creator: U.S. Food and Drug Administration
Published: 1994-03-18

Substantially Equivalent

Aerotel, Ltd.

FDA 510(k) clearance K930314 for HEARTLINE TRANSTELEPHONIC ECG RECEIVING CONSOLE, Substantially Equivalent on 1994-03-18. 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: 1993-01-22
Decision date: 1994-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Israel, IL

Download summary PDF View on FDA.gov ↗

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