The following data is part of a premarket notification filed by Nds Surgical Imaging with the FDA for Primevue 21 3mp Color Display, Model Ac-qx21-a9300.
| Device ID | K080320 |
| 510k Number | K080320 |
| Device Name: | PRIMEVUE 21 3MP COLOR DISPLAY, MODEL AC-QX21-A9300 |
| Classification | System, Image Processing, Radiological |
| Applicant | NDS SURGICAL IMAGING 5750 HELLYER AVENUE San Jose, CA 95138 |
| Contact | Jim Lang |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-02-06 |
| Decision Date | 2008-02-21 |
| Summary: | summary |