| Device Classification Name |
endoscopic video imaging system/component, gastroenterology-urology |
|||
|---|---|---|---|---|
| 510(k) Number | K992362 | |||
| Device Name | FLEXISCOPE IQ 101 | |||
| Applicant |
|
|||
| Applicant Contact | joseph ress | |||
| Correspondent |
|
|||
| Correspodent Contact | joseph ress | |||
| Regulation Number | 876.1500 | |||
| Classification Product Code |
|
|||
| Date Received | 07/15/1999 | |||
| Decision Date | 08/05/1999 | |||
| Decision |
substantially equivalent (SESE) |
|||
| Regulation Medical Specialty |
Gastroenterology/Urology |
|||
| 510k Review Panel |
General & Plastic Surgery |
|||
| statement |
statement |
|||
| Type | Traditional | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |