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510(k) K760635

MEDI-DYNE APNEA MONITOR by Med Dyne Inst., Inc. — Product Code FLS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1976
Date Received
September 13, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Apnea, Facility Use
Device Class
Class II
Regulation Number
868.2377
Review Panel
AN
Submission Type

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