Device Classification Name |
analyzer, gas, carbon-dioxide, gaseous-phase
|
510(k) Number |
K040011 |
Device Name |
POLARIS 2004 CAPNOGRAPH |
Applicant |
ORIDION LTD. |
21 HIGHLAND CIRCLE |
NEEDHAM,
MA
02494 -3038
|
|
Applicant Contact |
DOMINIC CORSALE |
Correspondent |
ORIDION LTD. |
21 HIGHLAND CIRCLE |
NEEDHAM,
MA
02494 -3038
|
|
Correspondent Contact |
DOMINIC CORSALE |
Regulation Number | 868.1400
|
Classification Product Code |
|
Date Received | 01/05/2004 |
Decision Date | 05/13/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|