The following data is part of a premarket notification filed by Vision-sciences, Inc. with the FDA for Video Sciences Brs-5000 Video Bronchoscope With Endosheath System, Dpu-5000/dpu-5050 Video Processor & Accessories.
| Device ID | K091768 |
| 510k Number | K091768 |
| Device Name: | VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIES |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | VISION-SCIENCES, INC. 40 RAMLAND RD. SOUTH Orangeburg, NY 10962 |
| Contact | Lillian Quintero |
| Correspondent | Lillian Quintero VISION-SCIENCES, INC. 40 RAMLAND RD. SOUTH Orangeburg, NY 10962 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-16 |
| Decision Date | 2009-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00874485003135 | K091768 | 000 |
| 00874485002848 | K091768 | 000 |
| 00874485003029 | K091768 | 000 |
| 00874485003036 | K091768 | 000 |
| 00874485003043 | K091768 | 000 |
| 00874485003050 | K091768 | 000 |
| 00874485003067 | K091768 | 000 |
| 00874485003074 | K091768 | 000 |
| 00874485003098 | K091768 | 000 |
| 00874485003104 | K091768 | 000 |
| 00874485003111 | K091768 | 000 |
| 00874485003128 | K091768 | 000 |
| 00874485002367 | K091768 | 000 |