The following data is part of a premarket notification filed by Acueity, Inc. with the FDA for Viaduct Miniscope And Accessories.
| Device ID | K040949 |
| 510k Number | K040949 |
| Device Name: | VIADUCT MINISCOPE AND ACCESSORIES |
| Classification | Light Source, Endoscope, Xenon Arc |
| Applicant | ACUEITY, INC. 100 HAMILTON AVE., SUITE 140 Palo Alto, CA 94301 |
| Contact | Nancy Lince |
| Correspondent | J.a. Van Vugt KEMA QUALITY B.V. P.O. BOX 5185 6802 ED ARNHEM Arnhem, NL |
| Product Code | GCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-04-12 |
| Decision Date | 2004-05-07 |
| Summary: | summary |