HEART 1001— 510(k) K931020

Substantially Equivalent

Aerotel, Ltd.

FDA 510(k) clearance K931020 for HEART 1001, Substantially Equivalent on 1995-01-11. Applicant: Aerotel, Ltd..

Clearance details

Applicant: Aerotel, Ltd.
Product code: Code DXH
Advisory panel: Cardiovascular
Date received: 1993-02-26
Decision date: 1995-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rutherford, NJ, US

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