The following data is part of a premarket notification filed by Acueity, Inc. with the FDA for Acueity Medical Light Source.
| Device ID | K032430 |
| 510k Number | K032430 |
| Device Name: | ACUEITY MEDICAL LIGHT SOURCE |
| Classification | Light Source, Fiberoptic, Routine |
| Applicant | ACUEITY, INC. 100 HAMILTON AVE., SUITE 140 Palo Alto, CA 94301 |
| Contact | Nancy Lince |
| Correspondent | P.n. Ruys N.V. KEMA P.O. BOX 9035 6800 ET ARNHEM Arnhem, NL |
| Product Code | FCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-08-06 |
| Decision Date | 2003-09-05 |
| Summary: | summary |