The following data is part of a premarket notification filed by Impac Medical Systems, Inc. with the FDA for Mlc Fit.
| Device ID | K962335 |
| 510k Number | K962335 |
| Device Name: | MLC FIT |
| Classification | Accelerator, Linear, Medical |
| Applicant | IMPAC MEDICAL SYSTEMS, INC. 215 CASTRO ST. Mountain View, CA 94041 -1203 |
| Contact | Joseph K Jachinowski |
| Correspondent | Joseph K Jachinowski 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 | 1996-06-17 |
| Decision Date | 1997-02-06 |
| Summary: | summary |