Device Classification Name |
Monitor, Carbon-Dioxide, Cutaneous
|
510(k) Number |
K900333 |
Device Name |
E5280 COMBINED TRANSCUTANEOUS TCP02/TCPCO2 ELECT. |
Applicant |
RADIOMETER AMERICA, INC. |
811 SHARON DR. |
WESTLAKE,
OH
44145 -1598
|
|
Applicant Contact |
DONALD BAKER |
Correspondent |
RADIOMETER AMERICA, INC. |
811 SHARON DR. |
WESTLAKE,
OH
44145 -1598
|
|
Correspondent Contact |
DONALD BAKER |
Regulation Number | 868.2480
|
Classification Product Code |
|
Date Received | 01/23/1990 |
Decision Date | 04/16/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|