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510(k) K061870

VITALSENSE XHR by Respironics, Inc. — Product Code GWK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2006
Date Received
July 3, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K872290 — BIO-LOGIC BANKER (October 6, 1987)
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