K220976 is an FDA 510(k) clearance for the Life Scope PT BSM-1700 Series Bedside Monitor. This device is classified as a Stimulator, Nerve, Peripheral, Electric (Class II - Special Controls, product code KOI).
Submitted by Nihon Kohden Corporation (Tokyo, JP). The FDA issued a Cleared decision on July 21, 2022, 108 days after receiving the submission on April 4, 2022.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2775.
| 510(k) Number | K220976 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 2022 |
| Decision Date | July 21, 2022 |
| Days to Decision | 108 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | KOI - Stimulator, Nerve, Peripheral, Electric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2775 |