| Device Classification Name |
Analyzer, Gas, Oxygen, Gaseous-Phase
|
| 510(k) Number |
K990403 |
| Device Name |
TED 200T7 OXYGEN MONITOR |
| Applicant |
| Teledyne Electronic Technologies |
| 16830 Chestnut St. |
|
City Of Industry,
CA
|
|
| Applicant Contact |
RAY KHAJAVI |
| Correspondent |
| Teledyne Electronic Technologies |
| 16830 Chestnut St. |
|
City Of Industry,
CA
|
|
| Correspondent Contact |
RAY KHAJAVI |
| Regulation Number | 868.1720 |
| Classification Product Code |
|
| Date Received | 02/09/1999 |
| Decision Date | 02/03/2000 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Statement |
Statement
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|