The following data is part of a premarket notification filed by 3d-shaper Medical S.l with the FDA for 3d-shaper.
Device ID | K220822 |
510k Number | K220822 |
Device Name: | 3D-SHAPER |
Classification | Densitometer, Bone |
Applicant | 3D-Shaper Medical S.L C/ Paris 179, 2-2 Barcelona, ES 08036 |
Contact | Ludovic Humbert |
Correspondent | Ludovic Humbert 3D-Shaper Medical S.L C/ Paris 179, 2-2 Barcelona, ES 08036 |
Product Code | KGI |
CFR Regulation Number | 892.1170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-03-21 |
Decision Date | 2022-12-09 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08437021740028 | K220822 | 000 |