Device Classification Name |
spirometer, monitoring (w/wo alarm)
|
510(k) Number |
K080652 |
Device Name |
MERCURY VCO2 MODULE WITH CAPNOSTAT 5 |
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 | 868.1850
|
Classification Product Code |
|
Date Received | 03/07/2008 |
Decision Date | 06/20/2008 |
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
|
|
|