Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
510(k) Number |
K053174 |
Device Name |
LOFLO C5 CO2 SENSOR |
Applicant |
RESPIRONICS NOVAMETRIX LLC |
5 TECHNOLOGY DRIVE |
WALLINGFORD,
CT
06492
|
|
Applicant Contact |
KEVIN MADER |
Correspondent |
RESPIRONICS NOVAMETRIX LLC |
5 TECHNOLOGY DRIVE |
WALLINGFORD,
CT
06492
|
|
Correspondent Contact |
KEVIN MADER |
Regulation Number | 868.1400
|
Classification Product Code |
|
Date Received | 11/14/2005 |
Decision Date | 01/12/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|