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 |