| Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
| 510(k) Number |
K843285 |
| Device Name |
TRI-MED 610 CAPNOSTAT GAS ANALYZER |
| Applicant |
| Tri-Med, Inc. |
| 10301 Willows Rd. |
|
Redmond,
WA
98005
|
|
| Applicant Contact |
BERT POST |
| Correspondent |
| Tri-Med, Inc. |
| 10301 Willows Rd. |
|
Redmond,
WA
98005
|
|
| Correspondent Contact |
BERT POST |
| Regulation Number | 868.1400 |
| Classification Product Code |
|
| Date Received | 08/21/1984 |
| Decision Date | 11/13/1984 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|