The following data is part of a premarket notification filed by Villa Sistemi Medicali S.p.a. with the FDA for Rotograph Evo 3d.
Device ID | K111152 |
510k Number | K111152 |
Device Name: | ROTOGRAPH EVO 3D |
Classification | System, X-ray, Extraoral Source, Digital |
Applicant | VILLA SISTEMI MEDICALI S.P.A. VIA DELLE AZALEE 3 Buccinasco, IT 20090 |
Contact | Paolo Casagrande Santin |
Correspondent | Paolo Casagrande Santin VILLA SISTEMI MEDICALI S.P.A. VIA DELLE AZALEE 3 Buccinasco, IT 20090 |
Product Code | MUH |
CFR Regulation Number | 872.1800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-04-25 |
Decision Date | 2011-07-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08052870661012 | K111152 | 000 |