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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 K092685
Device Name PNEUMOTHERML, MODEL: 5800
Applicant
SALTER LABS
100 W. SYCAMORE RD.
ARVIN,  CA  93203
Applicant Contact TERRY NEWTON
Correspondent
SALTER LABS
100 W. SYCAMORE RD.
ARVIN,  CA  93203
Correspondent Contact TERRY NEWTON
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received09/02/2009
Decision Date 11/24/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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