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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name calculator, pulmonary function interpretor (diagnostic)
510(k) Number K831586
Device Name CM-VII PHYSIOLOGIC ANALYZER
Applicant
CYBERMEDIC, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
CYBERMEDIC, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.1900
Classification Product Code
BZM  
Date Received05/17/1983
Decision Date 03/19/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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