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510(k) K092991

O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING) by Environmental Tectonics Corp. — Product Code CBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2010
Date Received
September 28, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Chamber, Hyperbaric
Device Class
Class II
Regulation Number
868.5470
Review Panel
AN
Submission Type

Other clearances by Environmental Tectonics Corp.

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