The following data is part of a premarket notification filed by Nihon Kohden Corp. with the FDA for Nihon Khden Prefense Edns-9000 Series Central Nurse Station.
| Device ID | K102106 |
| 510k Number | K102106 |
| Device Name: | NIHON KHDEN PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | NIHON KOHDEN CORP. 90 ICON STREET Foothill, CA 92610 |
| Contact | Steve Geerdes |
| Correspondent | Steve Geerdes NIHON KOHDEN CORP. 90 ICON STREET Foothill, CA 92610 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-27 |
| Decision Date | 2010-12-17 |
| Summary: | summary |