ART-ASSIST MODEL AA-1000— 510(k) K942530

Substantially Equivalent

Aci Medical, Inc.

FDA 510(k) clearance K942530 for ART-ASSIST MODEL AA-1000, Substantially Equivalent on 1996-02-28. Applicant: Aci Medical, Inc.. Device class: 2.

Clearance details

Applicant: Aci Medical, Inc.
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 1994-05-27
Decision date: 1996-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Marcos, CA, US

Download summary PDF View on FDA.gov ↗

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