The following data is part of a premarket notification filed by C.g.h. Medical, Inc. with the FDA for Centrysystem 3 With Charts/bp Option.
| Device ID | K925522 |
| 510k Number | K925522 |
| Device Name: | CENTRYSYSTEM 3 WITH CHARTS/BP OPTION |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | C.G.H. MEDICAL, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Contact | Vera Buffaloe |
| Correspondent | Vera Buffaloe C.G.H. MEDICAL, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-02 |
| Decision Date | 1994-09-30 |