The following data is part of a premarket notification filed by Visia Imaging S.r.l. with the FDA for Aladdin.
Device ID | K131567 |
510k Number | K131567 |
Device Name: | ALADDIN |
Classification | Biomicroscope, Slit-lamp, Ac-powered |
Applicant | VISIA Imaging S.r.l. 110 EAST GRANADA BLVD, STE 209 Ormond Beach, FL 32176 |
Contact | Claude Berthoin |
Correspondent | Claude Berthoin VISIA Imaging S.r.l. 110 EAST GRANADA BLVD, STE 209 Ormond Beach, FL 32176 |
Product Code | HJO |
CFR Regulation Number | 886.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-05-30 |
Decision Date | 2014-06-05 |
Summary: | summary |