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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, apnea, facility use
510(k) Number K991087
Device Name HANNAH WIRELESS VITAL SIGNS MONITOR
Applicant
ILIFE SYSTEMS, INC.
5910 N. CENTRAL EXPRESSWAY
SUITE 1775
DALLAS,  TX  75206
Applicant Contact JOSHUA A ADLER
Correspondent
ILIFE SYSTEMS, INC.
5910 N. CENTRAL EXPRESSWAY
SUITE 1775
DALLAS,  TX  75206
Correspondent Contact JOSHUA A ADLER
Regulation Number868.2377
Classification Product Code
FLS  
Subsequent Product Code
BZQ  
Date Received03/31/1999
Decision Date 01/12/2000
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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