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510(k) Data Aggregation
K Number
K082315Device Name
EC50 MICRO+ SMOKERLYZER
Manufacturer
BEDFONT SCIENTIFIC LTD.
Date Cleared
2010-02-01
(537 days)
Product Code
CCJ, DLJ, LAS
Regulation Number
868.1430Why did this record match?
Applicant Name (Manufacturer) :
BEDFONT SCIENTIFIC LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K070259Device Name
EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR
Manufacturer
BEDFONT SCIENTIFIC LTD.
Date Cleared
2008-02-21
(391 days)
Product Code
CCJ
Regulation Number
868.1430Why did this record match?
Applicant Name (Manufacturer) :
BEDFONT SCIENTIFIC LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EC50 ToxCO+ Breath Carbon Monoxide Monitor and accessories are used by healthcare professionals to determine levels of Carbon Monoxide (CO) poisoning.
Device Description
The EC50 ToxCO+ Breath Carbon Monoxide Monitor is a handheld device, which provides a non-invasive means of determining Carbon Monoxide (CO) poisoning and Carboxyhaemoglobin (COHb) when blood testing is not available. The EC50 ToxCO+ Breath Carbon Monoxide Monitor is also ideal for use during triage to ensure suspected cases of CO poisoning are not missed. The EC50 ToxCO+ Breath Carbon Monoxide Monitor is a microprocessor-controlled device powered by 2 AA batteries with an Alphanumerice LCD display housed in a sturdy ABS case with a synthetic rubber boot. The EC50 ToxCO+ Breath Carbon Monoxide Monitor is designed to have an operating temperature between 0-30° C, operating humidity 10-95% non-condensing and has storage temperature requirements of 0-30° C. The sensor sensitivity is 1 pmm, has a warm up time of <10 seconds-90% FSD, an accuracy of ±5% of reading, a concentration range of 0-50% COHb/0-500ppm CO and an H2 Cross Interference of <40% @ 20° C. The sensor operating life is 2-3 years with a company warranty of 6 months and requires calibrations at 6-month intervals. The EC50 ToxCO+ Breath Carbon Monoxide Monitor is an easy to use handheld device that has three clearly marked buttons: ON button, CAL calibration button, RECALL button.
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K Number
K000962Device Name
PICO SMOKERLYZER, MODEL EC-50
Manufacturer
BEDFONT SCIENTIFIC LTD.
Date Cleared
2000-04-20
(27 days)
Product Code
CCJ
Regulation Number
868.1430Why did this record match?
Applicant Name (Manufacturer) :
BEDFONT SCIENTIFIC LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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