The following data is part of a premarket notification filed by Base Ten Systems, Inc. with the FDA for Upacs Version 1.7.
Device ID | K961160 |
510k Number | K961160 |
Device Name: | UPACS VERSION 1.7 |
Classification | Device, Digital Image Storage, Radiological |
Applicant | BASE TEN SYSTEMS, INC. ONE ELECTTONICS DR. P.O. BOX 3151 TRENTON, NJ 08619 |
Contact | RICHARD J FARRELLY |
Correspondent | RICHARD J FARRELLY BASE TEN SYSTEMS, INC. ONE ELECTTONICS DR. P.O. BOX 3151 TRENTON, NJ 08619 |
Product Code | LMB |
CFR Regulation Number | 892.2010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-03-22 |
Decision Date | 1996-06-11 |