| Device Classification Name |
oximeter |
|||
|---|---|---|---|---|
| 510(k) Number | K992092 | |||
| Device Name | STAT-SHELL DISPOSABLE SPO2 SENSOR | |||
| Applicant |
|
|||
| Applicant Contact | krista oakes | |||
| Correspondent |
|
|||
| Correspodent Contact | krista oakes | |||
| Regulation Number | 870.2700 | |||
| Classification Product Code |
|
|||
| Date Received | 06/21/1999 | |||
| Decision Date | 12/22/1999 | |||
| Decision |
substantially equivalent (SESE) |
|||
| Regulation Medical Specialty |
Cardiovascular |
|||
| 510k Review Panel |
Anesthesiology |
|||
| summary |
summary |
|||
| Type | Traditional | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |