The following data is part of a premarket notification filed by Pausch Corp. with the FDA for Coordinatus, Horizontal Radiographoc.
Device ID | K790743 |
510k Number | K790743 |
Device Name: | COORDINATUS, HORIZONTAL RADIOGRAPHOC |
Classification | Table, Radiologic |
Applicant | PAUSCH CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KXJ |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-04-16 |
Decision Date | 1979-04-23 |