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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 LANE
UPCHURCH, SITTINGBOURNE, KENT
ME9 7HN ENGLAND,  GB
Applicant Contact SMITH
Correspondent
BEDFONT TECHNICAL INSTRUMENTS LTD.
BEDFONT HOUSE, HOLYWELL LANE
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
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