FDA 510(k) Applications for Medical Device Product Code "KOI"
(Stimulator, Nerve, Peripheral, Electric)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K192958 | Blink Device Company | TwitchView System | 04/02/2020 |
| K172843 | Blink Device Corporation | TwitchView System | 03/29/2018 |
| K955026 | DATEX MEDICAL INSTRUMENTATION, INC. | AS/3 NMT MODULE | 04/28/1997 |
| K042003 | Draeger Medical Systems, Inc. | INFINITY TRIDENT NMT POD | 09/01/2004 |
| K953205 | FISHER & PAYKEL HEALTHCARE, LTD. | CONSTANT CURRENT PERIPHERAL NERVE STIMULATOR NS272 (MODIFICATION) | 05/23/1996 |
| K051635 | GE HEALTHCARE | DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES | 07/15/2005 |
| K162048 | HALYARD HEALTH - IRVINE | EZstim*III Peripheral Nerve Stimulator/Nerve Locator | 12/05/2016 |
| K023342 | HDC CORP. | NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III NERVE MAPPING PROBE, NEURO-TRACE III NERVE BG | 03/02/2004 |
| K172690 | Idmed | ToFscan | 05/31/2018 |
| K954505 | LIFE-TECH INTL., INC. | EZ STIM | 12/10/1996 |
| K955031 | LIFE-TECH INTL., INC. | MAXISTIM | 12/10/1996 |
| K212434 | MIPM Mammendorfer Institut fⁿr Physik und Medizin GmbH | Neuromuscular Transmission Monitor TOF3D | 05/05/2022 |
| K002889 | NEOTONUS, INC. | PNS MAGNETIC STIMULATOR SYSTEM | 04/06/2001 |
| K220976 | Nihon Kohden Corporation | Life Scope PT BSM-1700 Series Bedside Monitor | 07/21/2022 |
| K213316 | Nihon Kohden Corporation | Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM | 12/29/2021 |
| K201949 | Nihon Kohden Corporation | Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series | 05/02/2021 |
| K972698 | ORGANON TEKNIKA CORP. | TOF-WATCH | 12/16/1997 |
| K992596 | ORGANON TEKNIKA CORP. | TOF-WATCH S | 08/30/1999 |
| K992598 | ORGANON TEKNIKA CORP. | TOF-WATCH SX | 08/30/1999 |
| K190795 | Senzime AB | Tetragraph Neuromuscular Transmission Monitor | 10/18/2019 |
| K220530 | Senzime AB | Tetragraph Neuromuscular Transmission Monitor | 08/17/2022 |
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