The following data is part of a premarket notification filed by Imt America, Inc. with the FDA for Mtt 90 Universal Remote-controlled X-ray Table.
Device ID | K901654 |
510k Number | K901654 |
Device Name: | MTT 90 UNIVERSAL REMOTE-CONTROLLED X-RAY TABLE |
Classification | Table, Radiographic, Tilting |
Applicant | IMT AMERICA, INC. 120 EAST BALTIMORE ST. Baltimore, MD 21202 |
Contact | Peggy Chaplin |
Correspondent | Peggy Chaplin IMT AMERICA, INC. 120 EAST BALTIMORE ST. Baltimore, MD 21202 |
Product Code | IXR |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-04-10 |
Decision Date | 1990-11-23 |