The following data is part of a premarket notification filed by Impac Medical Systems, Inc. with the FDA for Mlc Fit.
| Device ID | K991133 |
| 510k Number | K991133 |
| Device Name: | MLC FIT |
| Classification | Accelerator, Linear, Medical |
| Applicant | IMPAC MEDICAL SYSTEMS, INC. 215 CASTRO ST. Mountain View, CA 94041 -1203 |
| Contact | Thomas Faris |
| Correspondent | Thomas Faris IMPAC MEDICAL SYSTEMS, INC. 215 CASTRO ST. Mountain View, CA 94041 -1203 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-02 |
| Decision Date | 2000-03-27 |
| Summary: | summary |