FDA 510(k) Application Details - K023354

Device Classification Name Compressor, Air, Portable

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510(K) Number K023354
Device Name Compressor, Air, Portable
Applicant SIEMENS ELEMA AB
16 ELECTRONICS AVE.
DANVERS, MA 01923 US
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Contact STEVE SHEEHAN
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Regulation Number 868.6250

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Classification Product Code BTI
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Date Received 10/07/2002
Decision Date 09/05/2003
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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