FDA 510(k) Application Details - K971184

Device Classification Name Ventilatory Effort Recorder

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510(K) Number K971184
Device Name Ventilatory Effort Recorder
Applicant SNAP LABORATORIES, L.L.C.
3633 WEST LAKE AVE., SUITE 406
GLENVIEW, IL 60025 US
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Contact GIL RAVIV
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Regulation Number 868.2375

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Classification Product Code MNR
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Date Received 04/01/1997
Decision Date 10/01/1997
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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