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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 K892841
Device Name BEDFONT EC50 SMOKERLYZER CARBON MONOXIDE MONITOR
Applicant
Bedfont Technical Instruments , Ltd.
Bedfont House, Holywell Ln.
Upchurch, Sittingbourne, Kent
Me9 7hn England,  GB
Applicant Contact SMITH
Correspondent
Bedfont Technical Instruments , Ltd.
Bedfont House, Holywell Ln.
Upchurch, Sittingbourne, Kent
Me9 7hn England,  GB
Correspondent Contact SMITH
Regulation Number868.1430
Classification Product Code
CCJ  
Date Received04/18/1989
Decision Date 10/05/1989
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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