HEART 400 ECG TRANSMITTER— 510(k) K953762

Substantially Equivalent

Aerotel, Ltd.

FDA 510(k) clearance K953762 for HEART 400 ECG TRANSMITTER, Substantially Equivalent on 1996-07-18. 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: 1995-08-11
Decision date: 1996-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Israel, IL

Download summary PDF View on FDA.gov ↗

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More clearances from Aerotel, Ltd.

K980144 — HEARTVIEW P12/8 ELECTROCARDIOGRAPH RECORDER AND TRANSMITTER1998-06-16
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K950004 — HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTER1995-10-24
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Data sourced from openFDA. This site is unofficial and independent of the FDA.