FDA 510(k) Application Details - K001121

Device Classification Name Chamber, Hyperbaric

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510(K) Number K001121
Device Name Chamber, Hyperbaric
Applicant ENGINEERED MEDICAL TECHNOLOGY, INC.
7303 HOUSTON HWY.
P.O. BOX 1939
VICTORIA, TX 77902 US
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Contact DON SCHMIELEY
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Regulation Number 868.5470

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Classification Product Code CBF
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Date Received 04/07/2000
Decision Date 11/29/2001
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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