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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
510(k) Number K781271
Device Name MONITOR, PO2, INTRAVASCULAR
Applicant
ROCHE MEDICAL ELECTRONICS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
ROCHE MEDICAL ELECTRONICS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.1200
Classification Product Code
CCE  
Date Received07/24/1978
Decision Date 10/12/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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