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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 K892524
Device Name VITALOGRAPH-BREATHCO MONITOR
Applicant
VITALOGRAPH LTD.
8347 QUIVIRA RD.
LENEXA,  KS  66215
Applicant Contact LOVINA FREEMAN
Correspondent
VITALOGRAPH LTD.
8347 QUIVIRA RD.
LENEXA,  KS  66215
Correspondent Contact LOVINA FREEMAN
Regulation Number868.1430
Classification Product Code
CCJ  
Date Received04/11/1989
Decision Date 05/05/1989
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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