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FDA 510(k) Application Details - K072688
Device Classification Name
Generator, Oxygen, Portable
More FDA Info for this Device
510(K) Number
K072688
Device Name
Generator, Oxygen, Portable
Applicant
INTERNATIONAL BIOPHYSICS CORP.
2101-2 E. ST. ELMO
SUITE 275
AUSTIN, TX 78744 US
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Contact
DAVID SHOCKLEY
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Regulation Number
868.5440
More FDA Info for this Regulation Number
Classification Product Code
CAW
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More FDA Info for this Product Code
Date Received
09/24/2007
Decision Date
01/11/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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