FDA 510(k) Application Details - K993269

Device Classification Name Ventilator, Non-Continuous (Respirator)

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510(K) Number K993269
Device Name Ventilator, Non-Continuous (Respirator)
Applicant SLEEPNET CORPORATION
1050 PERIMETER RD.,
LOCKHEED AIR CENTER
MANCHESTER, NH 03103 US
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Contact PAUL R CHIESA
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Regulation Number 868.5905

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Classification Product Code BZD
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Date Received 09/30/1999
Decision Date 10/27/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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