K203435 is an FDA 510(k) clearance for the Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System. 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 July 16, 2021, 235 days after receiving the submission on November 23, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K203435 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 2020 |
| Decision Date | July 16, 2021 |
| Days to Decision | 235 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 |