The following data is part of a premarket notification filed by Vision-sciences, Inc. with the FDA for Flexible Trans-nasal Video Esophagoscope With Digital Video Processor And Disposable Endosheath Systems.
| Device ID | K072088 |
| 510k Number | K072088 |
| Device Name: | FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOSABLE ENDOSHEATH SYSTEMS |
| Classification | Esophagoscope (flexible Or Rigid) |
| Applicant | VISION-SCIENCES, INC. 5 WHITCOMB AVE. Ayer, MA 01432 |
| Contact | Pamela Papineau |
| Correspondent | Pamela Papineau VISION-SCIENCES, INC. 5 WHITCOMB AVE. Ayer, MA 01432 |
| Product Code | EOX |
| CFR Regulation Number | 874.4710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-30 |
| Decision Date | 2007-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994657811 | K072088 | 000 |
| 20874485003016 | K072088 | 000 |
| 20874485002996 | K072088 | 000 |
| 00874485002879 | K072088 | 000 |
| 00874485000844 | K072088 | 000 |
| 20874485000770 | K072088 | 000 |