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510(k) K053229

MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS by Merits Health Products Co., Ltd. — Product Code CAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2006
Date Received
November 18, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Oxygen, Portable
Device Class
Class II
Regulation Number
868.5440
Review Panel
AN
Submission Type

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