The following data is part of a premarket notification filed by Imt America, Inc. with the FDA for Mte-t Radiogrphic/tomographic Elevating Table.
Device ID | K903921 |
510k Number | K903921 |
Device Name: | MTE-T RADIOGRPHIC/TOMOGRAPHIC ELEVATING TABLE |
Classification | Table, Radiographic, Non-tilting, Powered |
Applicant | IMT AMERICA, INC. 402 WEST TRADE ST. SUITE 200 GATEWAY PLAZA Charlotte, NC 28202 |
Contact | John Carpenter |
Correspondent | John Carpenter IMT AMERICA, INC. 402 WEST TRADE ST. SUITE 200 GATEWAY PLAZA Charlotte, NC 28202 |
Product Code | IZZ |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-24 |
Decision Date | 1990-12-04 |