510(k) K023475 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
CNS-9700 SERIES CENTRAL NURSE STATION AND ACCESSORIES
| Applicant | Nihon Kohden America, Inc., Foothill CA, US |
| Decision | Substantially Equivalent, Oct 24, 2002 |
| Received | Oct 16, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K023475
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 29, 2015 | Nihon Kohden America Inc Remote Network Station, Catalog RNS-9703, Model No. RNS-9703-19, RNS-9703-24, Software version 02.40.
The RNS 9703 is intended for use by medical professionals to provide secondary cardiac and vital Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.