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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, halothane, gaseous-phase (anesthetic conc.)
510(k) Number K863801
Device Name TMM MODEL 3000 ANESTHESIA CIRCUIT EVALUATOR
Applicant
TRAVERSE MEDICAL MONITORS
6812 S. STATE RD.
SALINE,  MI  48176
Applicant Contact TIMOTHY J BOMYA
Correspondent
TRAVERSE MEDICAL MONITORS
6812 S. STATE RD.
SALINE,  MI  48176
Correspondent Contact TIMOTHY J BOMYA
Regulation Number868.1620
Classification Product Code
CBS  
Date Received09/29/1986
Decision Date 01/12/1987
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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