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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter, Ear
510(k) Number K845051
Device Name VITALOG PMS-8
Applicant
VITALOG CORP.
2484 OLD MIDDLEFIELD WAY
MOUNTAIN VIEW,  CA  94043
Applicant Contact BRUCE RULE
Correspondent
VITALOG CORP.
2484 OLD MIDDLEFIELD WAY
MOUNTAIN VIEW,  CA  94043
Correspondent Contact BRUCE RULE
Regulation Number870.2710
Classification Product Code
DPZ  
Date Received12/19/1984
Decision Date 05/15/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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