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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilatory effort recorder
510(k) Number K981034
Device Name SILENT NIGHT II
Applicant
SLEEP SOLUTIONS, INC.
9223 ILONA LN.
HOUSTON,  TX  77025
Applicant Contact LISA S JONES
Correspondent
SLEEP SOLUTIONS, INC.
9223 ILONA LN.
HOUSTON,  TX  77025
Correspondent Contact LISA S JONES
Regulation Number868.2375
Classification Product Code
MNR  
Date Received03/19/1998
Decision Date 10/30/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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