HEARTVIEW P12/8 ELECTROCARDIOGRAPH RECORDER AND TRANSMITTER— 510(k) K980144

Name: FDA 510(k) clearance K980144
Creator: U.S. Food and Drug Administration
Published: 1998-06-16

Substantially Equivalent

Aerotel, Ltd.

FDA 510(k) clearance K980144 for HEARTVIEW P12/8 ELECTROCARDIOGRAPH RECORDER AND TRANSMITTER, Substantially Equivalent on 1998-06-16. 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: 1998-01-15
Decision date: 1998-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hasbrouck, NJ, US

Download summary PDF View on FDA.gov ↗

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