CARDIOMEDICS ECP SYSTEM— 510(k) K010261

Substantially Equivalent

Cardiomedics, Inc.

FDA 510(k) clearance K010261 for CARDIOMEDICS ECP SYSTEM, Substantially Equivalent on 2001-02-28. Applicant: Cardiomedics, Inc..

Clearance details

Applicant: Cardiomedics, Inc.
Product code: Code DRN
Advisory panel: Cardiovascular
Date received: 2001-01-29
Decision date: 2001-02-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

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