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510(k) K912620

OPOMAT MANUAL RESUSCITATOR VENTILATOR by Euro-Am Pharma, Inc. — Product Code BTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1991
Date Received
June 13, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Manual (Resuscitator)
Device Class
Class II
Regulation Number
868.5915
Review Panel
AN
Submission Type

Other clearances by Euro-Am Pharma, Inc.

  • K900588 — ACU-BAND ACCUPRESSURE WRIST BAND (February 22, 1990)

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