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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Breathing Frequency
510(k) Number K080922
Device Name SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR
Applicant
SALTER LABS, DIVISION OF REGULATORY AFFAIRS
100 WEST SYCAMORE RD.
ARVIN,  CA  93203
Applicant Contact DUANE KAZAL
Correspondent
SALTER LABS, DIVISION OF REGULATORY AFFAIRS
100 WEST SYCAMORE RD.
ARVIN,  CA  93203
Correspondent Contact DUANE KAZAL
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received04/01/2008
Decision Date 07/25/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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