The following data is part of a premarket notification filed by Ptw-freiburg Physikalisch-technische-werkstaetten with the FDA for Veriqa.
| Device ID | K213370 |
| 510k Number | K213370 |
| Device Name: | VERIQA |
| Classification | Accelerator, Linear, Medical |
| Applicant | PTW-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychlau GmbH Loerracher Strasse 7 Freiburg, DE 79102 |
| Contact | Sandor-csaba Ats |
| Correspondent | Sandor-csaba Ats PTW-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychlau GmbH Loerracher Strasse 7 Freiburg, DE 79102 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-12 |
| Decision Date | 2022-03-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EPTWS070031 | K213370 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() VERIQA 79248101 not registered Live/Pending |
PTW - Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH 2018-10-15 |