FDA 510(k) Application Details - K982293

Device Classification Name Ventilatory Effort Recorder

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510(K) Number K982293
Device Name Ventilatory Effort Recorder
Applicant PRO-TECH SERVICES, INC.
12826 N.W. 178TH ST., SUITE A
P.O. BOX 2165
WOODINVILLE, WA 98072 US
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Contact ANTHONY ZARAGOZA
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Regulation Number 868.2375

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Classification Product Code MNR
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Date Received 07/01/1998
Decision Date 07/13/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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