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 |