HEART 2005— 510(k) K000775

Name: FDA 510(k) clearance K000775
Creator: U.S. Food and Drug Administration
Published: 2000-05-17

Substantially Equivalent

Aerotel Medical Systems (1998) , Ltd.

FDA 510(k) clearance K000775 for HEART 2005, Substantially Equivalent on 2000-05-17. Applicant: Aerotel Medical Systems (1998) , Ltd.. Device class: 2.

Clearance details

Applicant: Aerotel Medical Systems (1998) , Ltd.
Product code: Code DXH
Device class: Class 2
Regulation: 21 CFR 870.2920
Advisory panel: Cardiovascular
Date received: 2000-03-09
Decision date: 2000-05-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Hasbrouck Heights, NJ, US

Download summary PDF View on FDA.gov ↗

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