Submission Details
| 510(k) Number | K223567 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 29, 2022 |
| Decision Date | July 31, 2023 |
| Days to Decision | 244 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
CNS-2101 Central Monitor
Jul 2023
Decision
244d
Days
Class 2
Risk
About This 510(k) Submission
K223567 is an FDA 510(k) clearance for the CNS-2101 Central Monitor, a System, Network And Communication, Physiological Monitors (Class II — Special Controls, product code MSX), submitted by Nihon Kohden Corporation (Tokyo, JP). The FDA issued a Cleared decision on July 31, 2023, 244 days after receiving the submission on November 29, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.
Device Classification
| Product Code | MSX — System, Network And Communication, Physiological Monitors |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.2300 |
Manufacturer
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