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510(k) K082345

OXYGEN DEMAND VALVE by Bpr Medical, Ltd. — Product Code CBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2009
Date Received
August 15, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Valve, Non-Rebreathing
Device Class
Class II
Regulation Number
868.5870
Review Panel
AN
Submission Type

Other clearances by Bpr Medical, Ltd.

  • K943797 — BABYCARE NEO2 OXYGEN CONCENTRATION CONTROLLER (May 11, 1995)

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