FDA 510(k) Application Details - K955549

Device Classification Name Generator, Oxygen, Portable

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510(K) Number K955549
Device Name Generator, Oxygen, Portable
Applicant OXLIFE, INC.
1432 VISCAYA PKWY.
CAPE CORAL, FL 33990 US
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Contact STUART BASSINE
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Regulation Number 868.5440

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Classification Product Code CAW
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Date Received 12/05/1995
Decision Date 03/15/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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