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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
Predetermined Change
Control Plan Authorized		 No
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