FDA 510(k) Application Details - K991087

Device Classification Name Monitor, Apnea, Facility Use

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510(K) Number K991087
Device Name Monitor, Apnea, Facility Use
Applicant ILIFE SYSTEMS, INC.
5910 N. CENTRAL EXPRESSWAY
SUITE 1775
DALLAS, TX 75206 US
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Contact JOSHUA A ADLER
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Regulation Number 868.2377

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Classification Product Code FLS
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Date Received 03/31/1999
Decision Date 01/12/2000
Decision ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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