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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 K950273
Device Name SLEEP TEST(TM)
Applicant
CNS, INC.
1250 PARK RD.
CHANHASSEN,  MN  55317
Applicant Contact M.W. ANDY ANDERSON
Correspondent
CNS, INC.
1250 PARK RD.
CHANHASSEN,  MN  55317
Correspondent Contact M.W. ANDY ANDERSON
Regulation Number868.2375
Classification Product Code
MNR  
Date Received01/23/1995
Decision Date 09/19/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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