The following data is part of a premarket notification filed by General Electric Co. with the FDA for Ct Pace Catalog Number B7950a.
Device ID | K872526 |
510k Number | K872526 |
Device Name: | CT PACE CATALOG NUMBER B7950A |
Classification | System, X-ray, Tomography, Computed |
Applicant | GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
Contact | Howard, Ii |
Correspondent | Howard, Ii GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
Product Code | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-25 |
Decision Date | 1987-09-23 |