Device Classification Name |
analyzer, gas, oxygen, gaseous-phase
|
510(k) Number |
K944120 |
Device Name |
FI02 SENSING MODULE |
Applicant |
CORE-M, L.P. |
129 BRAINTREE ST. |
ALLSTON,
MA
02134
|
|
Applicant Contact |
NATAN E PARSONS |
Correspondent |
CORE-M, L.P. |
129 BRAINTREE ST. |
ALLSTON,
MA
02134
|
|
Correspondent Contact |
NATAN E PARSONS |
Regulation Number | 868.1720
|
Classification Product Code |
|
Date Received | 08/23/1994 |
Decision Date | 05/10/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|