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510(k) K052489

ACTIHEART by Respironics, Inc. — Product Code GWK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2005
Date Received
September 12, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Conditioner, Signal, Physiological
Device Class
Class II
Regulation Number
882.1845
Review Panel
NE
Submission Type

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