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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 K000962
Device Name PICO SMOKERLYZER, MODEL EC-50
Applicant
BEDFONT SCIENTIFIC LTD.
BEDFONT HOUSE
HOLYWELL LANE
UPCHURCH, KENT,  GB ME9 7HN
Applicant Contact MARTIN FOXLEY
Correspondent
BEDFONT SCIENTIFIC LTD.
BEDFONT HOUSE
HOLYWELL LANE
UPCHURCH, KENT,  GB ME9 7HN
Correspondent Contact MARTIN FOXLEY
Regulation Number868.1430
Classification Product Code
CCJ  
Date Received03/24/2000
Decision Date 04/20/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Clinical Chemistry
Type Special
Reviewed by Third Party No
Combination Product No
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