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510(k) K924341

HAYEK OSCILLATOR(TM) by Respironics, Inc. — Product Code BYT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1993
Date Received
August 27, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, External Body, Negative Pressure, Adult (Cuirass)
Device Class
Class II
Regulation Number
868.5935
Review Panel
AN
Submission Type

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