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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-Monoxide, Gaseous-Phase
510(k) Number K863420
Device Name VITALOGRAPH EC-50 CARBON MONOXIDE MONITOR
Applicant
VITALOGRAPH LTD.
8347 QUIVIRA RD.
LENEXA,  KS  66215
Applicant Contact LOVINA G FREEMAN
Correspondent
VITALOGRAPH LTD.
8347 QUIVIRA RD.
LENEXA,  KS  66215
Correspondent Contact LOVINA G FREEMAN
Regulation Number868.1430
Classification Product Code
CCJ  
Date Received09/04/1986
Decision Date 01/15/1987
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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