The following data is part of a premarket notification filed by Nds Surgical Imaging with the FDA for Zerowire Duo Wireless Hd Video Transfer System, Or Zero Wire.
| Device ID | K131115 |
| 510k Number | K131115 |
| Device Name: | ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, OR ZERO WIRE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | NDS SURGICAL IMAGING 5750 HELLYER AVENUE San Jose, CA 95138 |
| Contact | Jim Leng |
| Correspondent | Jim Leng NDS SURGICAL IMAGING 5750 HELLYER AVENUE San Jose, CA 95138 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-19 |
| Decision Date | 2013-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851455007584 | K131115 | 000 |
| 00851455007386 | K131115 | 000 |
| 00851455007379 | K131115 | 000 |
| 00851455007362 | K131115 | 000 |
| 00851455007355 | K131115 | 000 |
| 00851455007348 | K131115 | 000 |
| 00851455007331 | K131115 | 000 |
| 00851455007324 | K131115 | 000 |
| 00851455007317 | K131115 | 000 |
| 00851455007300 | K131115 | 000 |
| 00851455007294 | K131115 | 000 |
| 00851455007287 | K131115 | 000 |
| 00851455007393 | K131115 | 000 |
| 00851455007430 | K131115 | 000 |
| 00851455007447 | K131115 | 000 |
| 00851455007577 | K131115 | 000 |
| 00851455007560 | K131115 | 000 |
| 00851455007553 | K131115 | 000 |
| 00851455007546 | K131115 | 000 |
| 00851455007539 | K131115 | 000 |
| 00851455007522 | K131115 | 000 |
| 00851455007515 | K131115 | 000 |
| 00851455007508 | K131115 | 000 |
| 00851455007492 | K131115 | 000 |
| 00851455007461 | K131115 | 000 |
| 00851455007454 | K131115 | 000 |
| 00851455007270 | K131115 | 000 |