The following data is part of a premarket notification filed by U.s. Imaging, Inc. with the FDA for Photomulitplier Tube Interface P.c. Board.
Device ID | K890878 |
510k Number | K890878 |
Device Name: | PHOTOMULITPLIER TUBE INTERFACE P.C. BOARD |
Classification | System, X-ray, Fluoroscopic, Image-intensified |
Applicant | U.S. IMAGING, INC. 4816 MASSILLON RD. Greensburg, OH 44232 |
Contact | Charles Blouir |
Correspondent | Charles Blouir U.S. IMAGING, INC. 4816 MASSILLON RD. Greensburg, OH 44232 |
Product Code | JAA |
CFR Regulation Number | 892.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-02-21 |
Decision Date | 1989-03-14 |