The following data is part of a premarket notification filed by Lap Gmbh Laser Applikationen with the FDA for Thales 3d Mr Scanner.
Device ID | K200907 |
510k Number | K200907 |
Device Name: | Thales 3D Mr Scanner |
Classification | Accelerator, Linear, Medical |
Applicant | LAP GmbH Laser Applikationen Zeppelinstrasse 23 Lueneburg, DE 21335 |
Contact | Martin Pfabel |
Correspondent | Martin Pfabel LAP GmbH Laser Applikationen Zeppelinstrasse 23 Lueneburg, DE 21335 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-04-06 |
Decision Date | 2020-06-03 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04260590370754 | K200907 | 000 |
04260590370747 | K200907 | 000 |
04260590372345 | K200907 | 000 |
04260590372338 | K200907 | 000 |
04260590372383 | K200907 | 000 |
04260590372376 | K200907 | 000 |
04260590372369 | K200907 | 000 |
04260590372352 | K200907 | 000 |