The following data is part of a premarket notification filed by Comview Corp. with the FDA for Writestar, And Viewstar.
| Device ID | K964274 |
| 510k Number | K964274 |
| Device Name: | WRITESTAR, AND VIEWSTAR |
| Classification | Device, Digital Image Storage, Radiological |
| Applicant | COMVIEW CORP. 31 ALBANY POST RD. SUITE #7 Montrose, NY 10548 |
| Contact | Shailander Mangla |
| Correspondent | Shailander Mangla COMVIEW CORP. 31 ALBANY POST RD. SUITE #7 Montrose, NY 10548 |
| Product Code | LMB |
| CFR Regulation Number | 892.2010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-25 |
| Decision Date | 1997-01-10 |
| Summary: | summary |