The following data is part of a premarket notification filed by Innovative Endoscopy Components, Llc. with the FDA for Iec Medsight And Medbright.
| Device ID | K080809 |
| 510k Number | K080809 |
| Device Name: | IEC MEDSIGHT AND MEDBRIGHT |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | INNOVATIVE ENDOSCOPY COMPONENTS, LLC. 731-733 SHOTGUN RD. Ft. Lauderdale, FL 33326 |
| Contact | Gerald Goifitzer |
| Correspondent | Gerald Goifitzer INNOVATIVE ENDOSCOPY COMPONENTS, LLC. 731-733 SHOTGUN RD. Ft. Lauderdale, FL 33326 |
| Product Code | FET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-21 |
| Decision Date | 2008-08-11 |
| Summary: | summary |