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510(k) K894649

EMERSON 33-CR CHEST RESPIRATOR by Emerson Intl. Co. — Product Code BYT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1989
Date Received
July 24, 1989
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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