The following data is part of a premarket notification filed by Impax Technology, Inc. with the FDA for Dds, Ds3000, Rs3000, Cs5000, Ot3000, Is3000, Rs5000, Cd3000, Us3000, (amongst Other Names).
| Device ID | K993532 |
| 510k Number | K993532 |
| Device Name: | DDS, DS3000, RS3000, CS5000, OT3000, IS3000, RS5000, CD3000, US3000, (AMONGST OTHER NAMES) |
| Classification | System, Image Processing, Radiological |
| Applicant | IMPAX TECHNOLOGY, INC. 455 PHILLIP ST. Waterloo, Ontario, CA N2l 3x2 |
| Contact | Paula Pfeifle |
| Correspondent | Paula Pfeifle IMPAX TECHNOLOGY, INC. 455 PHILLIP ST. Waterloo, Ontario, CA N2l 3x2 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-19 |
| Decision Date | 1999-12-15 |
| Summary: | summary |