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FDA 510(k) Application Details - K991087
Device Classification Name
Monitor, Apnea, Facility Use
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
868.2377
More FDA Info for this Regulation Number
Classification Product Code
FLS
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More FDA Info for this Product Code
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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