The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Prefense Edns-9000 Series Nurse Central Station.
| Device ID | K073550 |
| 510k Number | K073550 |
| Device Name: | PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601 |
| Contact | Jack Coggan |
| Correspondent | Jack Coggan NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-18 |
| Decision Date | 2008-03-28 |
| Summary: | summary |