The following data is part of a premarket notification filed by Nihon Kohden Corp. with the FDA for Nihon Kohden Cns-6200 Series Central Nurse Station, Model Cns-6201.
| Device ID | K102376 |
| 510k Number | K102376 |
| Device Name: | NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201 |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | NIHON KOHDEN CORP. 90 ICON STREET Foothill Ranch, CA 92610 |
| Contact | Steve Geerdes |
| Correspondent | Steve Geerdes NIHON KOHDEN CORP. 90 ICON STREET Foothill Ranch, CA 92610 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-20 |
| Decision Date | 2010-12-07 |
| Summary: | summary |