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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 K840102
Device Name ARTERIAL BLOOD GAS INTERPRETATION PROG
Applicant
M. D. Software, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
M. D. Software, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number868.1200
Classification Product Code
CCE  
Date Received01/10/1984
Decision Date 02/04/1984
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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