FDA 510(k) Application Details - K960964

Device Classification Name Ventilator, Continuous, Facility Use

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510(K) Number K960964
Device Name Ventilator, Continuous, Facility Use
Applicant OHMEDA MEDICAL
OHMEDA DRIVE, P.O. BOX 7550
MADISON, WI 53707-7550 US
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Contact CHARLES MORREALE
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Regulation Number 868.5895

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Classification Product Code CBK
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Date Received 03/11/1996
Decision Date 09/27/1996
Decision ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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