The following data is part of a premarket notification filed by Infimed, Inc. with the FDA for Theraview.
Device ID | K960510 |
510k Number | K960510 |
Device Name: | THERAVIEW |
Classification | Accelerator, Linear, Medical |
Applicant | INFIMED, INC. 121 METROPOLITAN DR. Liverpool, NY 13088 |
Contact | Morteza Minaee |
Correspondent | Morteza Minaee INFIMED, INC. 121 METROPOLITAN DR. Liverpool, NY 13088 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-02-05 |
Decision Date | 1996-04-22 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08717953004055 | K960510 | 000 |
08717953004048 | K960510 | 000 |
08717953004031 | K960510 | 000 |
08717953004000 | K960510 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
THERAVIEW 75178450 not registered Dead/Abandoned |
Thermal Therapeutics, Inc. 1996-10-08 |
THERAVIEW 74113454 1681080 Live/Registered |
TARA LEUSDEN HOLDING BV 1990-11-08 |