The following data is part of a premarket notification filed by General Electric Co. with the FDA for Vrt Table.
Device ID | K827928 |
510k Number | K827928 |
Device Name: | VRT TABLE |
Classification | Table, Radiographic, Non-tilting, Powered |
Applicant | GENERAL ELECTRIC CO. 1 RIVER RD. Schenectady, NY 12345 |
Product Code | IZZ |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-08-17 |
Decision Date | 1982-09-29 |