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510(k) K021754

APEX MEDICAL DIGITAL EMS TS1311, TS1312 by Apex Medical Corp. — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2002
Date Received
May 29, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type

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  • K103174 — APEX MEDICAL WIZARD SERIES CPAP MASK (May 6, 2011)
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