| Device Classification Name |
Analyzer, Gas, Oxygen, Gaseous-Phase
|
| 510(k) Number |
K863158 |
| Device Name |
MODEL T-1 OXYGEN ANALYZER |
| Applicant |
| Chrysalis Systems, Inc. |
| Post Office Box 3395 |
|
Idaho Springs,
CO
80452
|
|
| Applicant Contact |
RON KNIGHT |
| Correspondent |
| Chrysalis Systems, Inc. |
| Post Office Box 3395 |
|
Idaho Springs,
CO
80452
|
|
| Correspondent Contact |
RON KNIGHT |
| Regulation Number | 868.1720 |
| Classification Product Code |
|
| Date Received | 08/18/1986 |
| Decision Date | 11/13/1986 |
| 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
|
|
|