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 |