The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Ct Scope.
Device ID | K974344 |
510k Number | K974344 |
Device Name: | CT SCOPE |
Classification | System, X-ray, Tomography, Computed |
Applicant | ELSCINT, INC. 86 ORCHARD ST. Hackensack, NJ 07601 |
Contact | Steven Kay |
Correspondent | Steven Kay ELSCINT, INC. 86 ORCHARD ST. Hackensack, NJ 07601 |
Product Code | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-11-19 |
Decision Date | 1998-06-03 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CT SCOPE 75440543 2302782 Dead/Cancelled |
VARCO I/P, INC. 1998-02-25 |