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 |