| Device Classification Name |
Analyzer, Gas, Oxygen, Gaseous-Phase
|
| 510(k) Number |
K001095 |
| Device Name |
OXYGEN SENSORS, MODELS CIR, C2R, R13, R15, RI7MED, R22MED, R23, R24MED, R29MED, T1, T2,T4, T7 & UFO130 |
| Applicant |
| Teledyne Analytical Instruments |
| 16830 Chestnut St. |
|
City Of Industry,
CA
91749
|
|
| Applicant Contact |
RAY KHAJAVI |
| Correspondent |
| Teledyne Analytical Instruments |
| 16830 Chestnut St. |
|
City Of Industry,
CA
91749
|
|
| Correspondent Contact |
RAY KHAJAVI |
| Regulation Number | 868.1720 |
| Classification Product Code |
|
| Date Received | 04/04/2000 |
| Decision Date | 06/30/2000 |
| 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
|
| Recalls |
CDRH Recalls
|
|
|