FDA 510(k) Application Details - K080321

Device Classification Name Ventilatory Effort Recorder

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510(K) Number K080321
Device Name Ventilatory Effort Recorder
Applicant SNAP LABORATORIES, L.L.C.
5210 CAPITOL DRIVE
WHEELING, IL 60090 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 02/06/2008
Decision Date 05/23/2008
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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