| Device Classification Name |
Analyzer, Gas, Oxygen, Gaseous-Phase
|
| 510(k) Number |
K024155 |
| Device Name |
MX 300 OXYGEN MONITOR |
| 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 | 12/17/2002 |
| Decision Date | 07/17/2003 |
| 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
|
|
|