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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 K051313
Device Name BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER
Applicant
SALTER LABS
100 W. SYCAMORE RD.
ARVIN,  CA  93203
Applicant Contact DUANE KAZAL
Correspondent
SALTER LABS
100 W. SYCAMORE RD.
ARVIN,  CA  93203
Correspondent Contact DUANE KAZAL
Regulation Number868.2375
Classification Product Code
MNR  
Date Received05/19/2005
Decision Date 09/15/2005
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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