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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, Carbon-Dioxide, Gaseous-Phase
510(k) Number K833397
Device Name TRI-MED 511 INFANT RESPIRATION MONITOR
Applicant
Tri-Med, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Tri-Med, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number868.1400
Classification Product Code
CCK  
Date Received09/30/1983
Decision Date 11/28/1983
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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