Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
510(k) Number |
K910509 |
Device Name |
PATIENT GAS SAMPLING LINE FOR OHMEDA 6000 |
Applicant |
INTERTECH RESOURCES, INC. |
5100 TICE ST. |
FT. MYERS,
FL
33905
|
|
Applicant Contact |
ROGERS |
Correspondent |
INTERTECH RESOURCES, INC. |
5100 TICE ST. |
FT. MYERS,
FL
33905
|
|
Correspondent Contact |
ROGERS |
Regulation Number | 868.1400
|
Classification Product Code |
|
Date Received | 02/05/1991 |
Decision Date | 04/17/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|