FDA 510(k) Application Details - K960490

Device Classification Name Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)

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510(K) Number K960490
Device Name Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
Applicant DATEX MEDICAL INSTRUMENTATION, INC.
2 HIGHWOOD DR.
TEWKSBURY, MA 01876 US
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Contact VINCENT RAUSCHER
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Regulation Number 868.1620

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Classification Product Code CBS
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Date Received 02/02/1996
Decision Date 05/03/1996
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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