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510(k) K014301

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2002
Date Received
December 31, 2001
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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