The following data is part of a premarket notification filed by Intraop Medical, Inc. with the FDA for Mobetron.
Device ID | K981112 |
510k Number | K981112 |
Device Name: | MOBETRON |
Classification | System, Radiation Therapy, Charged-particle, Medical |
Applicant | INTRAOP MEDICAL, INC. 3170 DE LA CRUZ BLVD., #108 Santa Clara, CA 95054 |
Contact | Donald A Goer |
Correspondent | Donald A Goer INTRAOP MEDICAL, INC. 3170 DE LA CRUZ BLVD., #108 Santa Clara, CA 95054 |
Product Code | LHN |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-03-26 |
Decision Date | 1998-07-24 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00861396000308 | K981112 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MOBETRON 85479743 4232738 Live/Registered |
INTRAOP MEDICAL CORPORATION 2011-11-23 |
MOBETRON 75615388 2432157 Dead/Cancelled |
INTRAOP MEDICAL, INC. 1999-01-04 |