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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 K862426
Device Name PULSE OXIMETER
Applicant
DRAEGER MEDICAL, INC.
148 B. QUARRY RD.
TELFORD,  PA  18969
Applicant Contact EDWARD T GRIFFITH
Correspondent
DRAEGER MEDICAL, INC.
148 B. QUARRY RD.
TELFORD,  PA  18969
Correspondent Contact EDWARD T GRIFFITH
Regulation Number870.2710
Classification Product Code
DPZ  
Date Received06/26/1986
Decision Date 09/11/1986
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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