FDA 510(k) Application Details - K022506

Device Classification Name Ventilatory Effort Recorder

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510(K) Number K022506
Device Name Ventilatory Effort Recorder
Applicant WIDEMED LTD
OMER INDUSTRIAL PARK, BLDG 8C
POB 3002
OMER 84965 IL
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Contact DAVID SOLOMON
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Regulation Number 868.2375

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Classification Product Code MNR
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Date Received 07/30/2002
Decision Date 05/15/2003
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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