The following data is part of a premarket notification filed by Shai Syg Motion And Innovations, Ltd. with the FDA for The Roboguide.
Device ID | K961849 |
510k Number | K961849 |
Device Name: | THE ROBOGUIDE |
Classification | System, X-ray, Mammographic |
Applicant | SHAI SYG MOTION AND INNOVATIONS, LTD. POB 6718 EFRAT, IL 90435 |
Contact | ELI M ORBACH |
Correspondent | ELI M ORBACH SHAI SYG MOTION AND INNOVATIONS, LTD. POB 6718 EFRAT, IL 90435 |
Product Code | IZH |
CFR Regulation Number | 892.1710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-05-13 |
Decision Date | 1996-08-21 |