ACTIHEART— 510(k) K052489

Substantially Equivalent

Respironics, Inc.

FDA 510(k) clearance K052489 for ACTIHEART, Substantially Equivalent on 2005-09-27. Applicant: Respironics, Inc..

Clearance details

Applicant: Respironics, Inc.
Product code: Code GWK
Advisory panel: Neurology
Date received: 2005-09-12
Decision date: 2005-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Murrysville, PA, US

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