The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Cns-9300 Series Central Station.
| Device ID | K001433 |
| 510k Number | K001433 |
| Device Name: | CNS-9300 SERIES CENTRAL STATION |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. Irvine, CA 92612 -1601 |
| Contact | Bonnie Bishop |
| Correspondent | Bonnie Bishop NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. Irvine, CA 92612 -1601 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-08 |
| Decision Date | 2000-11-07 |