| Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
| 510(k) Number |
K850746 |
| Device Name |
TRI-MED MODEL 126 SAMPLE LINE W/EXTENDED LIFE NAFI |
| 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 | 02/25/1985 |
| Decision Date | 04/02/1985 |
| 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
|
|
|