Submission Details
| 510(k) Number | K220976 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Special
Life Scope PT BSM-1700 Series Bedside Monitor
Jul 2022
Decision
108d
Days
Class 2
Risk
About This 510(k) Submission
K220976 is an FDA 510(k) clearance for the Life Scope PT BSM-1700 Series Bedside Monitor, 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 review panel. Regulated under 21 CFR 868.2775.
Device Classification
| Product Code | KOI — Stimulator, Nerve, Peripheral, Electric |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.2775 |
Manufacturer
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