510(k) K201949
- Device
- Smart Cable NMT Module And Accessories, Life Scope BSM 3000 Series And Life Scope BSM 6000 Series
- Applicant
- Nihon Kohden Corporation
- 510(k) number
- K201949
- Product code
- KOI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-05-02
- Date received
- 2020-07-13
- Regulation
- 868.2775
- Classification name
- Stimulator, Nerve, Peripheral, Electric
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Sandra Gadeyne
- Address
- 1-31-4 Nishiochiai, Shinjuki-Ku Tokyo JP 161-8560 161-8560
FDA Registration Numbers#
- 3005783425
- 8030229
- 3009077524
- 3013501110
- 3014447708
- 9611252
- 2085602
- 3016701404
- 3011270181
- 3013500228
- 3012072872
- 3008058135
- 3012528160
- 1219103
- 3000126629
- 3016618143
- 9610816
- 2221819
- 3021218757
- 3008892509
- 1651104
- 3032109181
- 3012606445
- 3008729547
- 3008114669
- 3016490024
- 3013679558
- 9610105
- 3009156722
- 3013596024
- 3042167988
- 3001570235
- 8043459
- 3007962724
- 3012359877
- 2183613
- 9710602
- 9710376
- 3003263092
- 3038371870
- 3012972516
- 3007770159
- 3013791928
- 3008483389
- 3007603826
- 3005877899
- 3016852448
- 3010838917
- 3009495681
- 3030733800
- 2080783
- 9611451
- 3008264255
Source Documents#
Other 510(k) Records For Product Code KOI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261098 | TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017) | Senzime AB | 2026-05-22 |
| K250887 | Neuromuscular Transmission Monitor TOF3D (2510091) | MIPM Mammendorfer Institut für Physik und Medizin GmbH | 2025-10-21 |
| K243339 | WiTOF | Idmed | 2025-06-23 |
| K242525 | iTOF® | Nerbio Medical Software Platforms, Inc. | 2024-12-05 |
| K220530 | Tetragraph Neuromuscular Transmission Monitor | Senzime AB | 2022-08-17 |
| K220976 | Life Scope PT BSM-1700 Series Bedside Monitor | Nihon Kohden Corporation | 2022-07-21 |
| K212434 | Neuromuscular Transmission Monitor TOF3D | MIPM Mammendorfer Institut für Physik und Medizin GmbH | 2022-05-05 |
| K213316 | 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 | Nihon Kohden Corporation | 2021-12-29 |
| K192958 | TwitchView System | Blink Device Company | 2020-04-02 |
| K190795 | Tetragraph Neuromuscular Transmission Monitor | Senzime AB | 2019-10-18 |
| K172690 | ToFscan | Idmed | 2018-05-31 |
| K172843 | TwitchView System | Blink Device Corporation | 2018-03-29 |
| K162048 | EZstim*III Peripheral Nerve Stimulator/Nerve Locator | Halyard Health - Irvine | 2016-12-05 |
| K051635 | DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES | GE Healthcare | 2005-07-15 |
| K042003 | INFINITY TRIDENT NMT POD | Draeger Medical Systems, Inc. | 2004-09-01 |
Legacy Summary#
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FDA Review#
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