K102106 is an FDA 510(k) clearance for the NIHON KHDEN PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION. This device is classified as a Transmitters And Receivers, Physiological Signal, Radiofrequency (Class II - Special Controls, product code DRG).
Submitted by Nihon Kohden Corp. (Foothill, US). The FDA issued a Cleared decision on December 17, 2010, 143 days after receiving the submission on July 27, 2010.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2910.
| 510(k) Number | K102106 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 27, 2010 |
| Decision Date | December 17, 2010 |
| Days to Decision | 143 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRG — Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2910 |