Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
510(k) Number |
K030886 |
FOIA Releasable 510(k) |
K030886
|
Device Name |
NICO WITH MARS, MODEL 7300 |
Applicant |
RESPIRONICS NOVAMETRIX, INC. |
5 TECHNOLOGY DR. |
WALLINGFORD,
CT
06492
|
|
Applicant Contact |
MICHAEL MALIS |
Correspondent |
RESPIRONICS NOVAMETRIX, INC. |
5 TECHNOLOGY DR. |
WALLINGFORD,
CT
06492
|
|
Correspondent Contact |
MICHAEL MALIS |
Regulation Number | 868.1400
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/21/2003 |
Decision Date | 10/07/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|