The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Synchron Cx4ce/cx5ce/cx7 Clinical Systems Software Update Version 4.0.
| Device ID | K951189 |
| 510k Number | K951189 |
| Device Name: | SYNCHRON CX4CE/CX5CE/CX7 CLINICAL SYSTEMS SOFTWARE UPDATE VERSION 4.0 |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. W-337 Brea, CA 92821 -6208 |
| Contact | Sheri Hall |
| Correspondent | Sheri Hall BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. W-337 Brea, CA 92821 -6208 |
| Product Code | JJE |
| Subsequent Product Code | CDQ |
| Subsequent Product Code | CEK |
| Subsequent Product Code | JFN |
| Subsequent Product Code | JJF |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-16 |
| Decision Date | 1995-06-13 |