The following data is part of a premarket notification filed by Smartlight, Ltd. with the FDA for Smart Motorized Viewer.
Device ID | K973965 |
510k Number | K973965 |
Device Name: | SMART MOTORIZED VIEWER |
Classification | Illuminator, Radiographic-film |
Applicant | SMARTLIGHT, LTD. 47 HATAASIYA ST. Nesher, IL 36602 |
Contact | Dan Ben-zeev |
Correspondent | Dan Ben-zeev SMARTLIGHT, LTD. 47 HATAASIYA ST. Nesher, IL 36602 |
Product Code | IXC |
CFR Regulation Number | 892.1890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-10-17 |
Decision Date | 1997-12-12 |
Summary: | summary |