The following data is part of a premarket notification filed by Chicago X-ray Systems, Inc. with the FDA for Rotograph Plus.
Device ID | K972968 |
510k Number | K972968 |
Device Name: | ROTOGRAPH PLUS |
Classification | Unit, X-ray, Extraoral With Timer |
Applicant | CHICAGO X-RAY SYSTEMS, INC. 219 MAYER AVE. Wheeling, IL 60090 |
Contact | Al Sosa |
Correspondent | Al Sosa CHICAGO X-RAY SYSTEMS, INC. 219 MAYER AVE. Wheeling, IL 60090 |
Product Code | EHD |
CFR Regulation Number | 872.1800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-08-11 |
Decision Date | 1997-10-08 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() ROTOGRAPH PLUS 78385684 3067465 Dead/Cancelled |
Villa Sistemi Medicali S.p.A. 2004-03-17 |