K163459 is an FDA 510(k) clearance for the Nihon Kohden Vital Sign Telemeter. This device is classified as a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MHX).
Submitted by Nihon Kohden Corporation (Tokyo, JP). The FDA issued a Cleared decision on April 4, 2017, 116 days after receiving the submission on December 9, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K163459 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 2016 |
| Decision Date | April 04, 2017 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MHX — Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1025 |