Device Classification Name |
Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
|
510(k) Number |
K070259 |
Device Name |
EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR |
Applicant |
BEDFONT SCIENTIFIC LTD. |
PO BOX 4341 |
CROFTON,
MD
21114
|
|
Applicant Contact |
E.J. Smith |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
DANIEL W LEHTONEN |
Regulation Number | 868.1430
|
Classification Product Code |
|
Date Received | 01/26/2007 |
Decision Date | 02/21/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|