FDA Product Code
FDA Product Code KOI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Anesthesiology
- 21 CFR Citation
- 868.2775
510(k) Clearances — 29 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| 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 | Special | PDF ↗ |
| K250887 | Neuromuscular Transmission Monitor TOF3D (2510091) | MIPM Mammendorfer Institut für Physik und Medizin GmbH | 2025-10-21 | Traditional | PDF ↗ |
| K243339 | WiTOF | Idmed | 2025-06-23 | Traditional | PDF ↗ |
| K242525 | iTOF® | Nerbio Medical Software Platforms, Inc. | 2024-12-05 | Traditional | PDF ↗ |
| K220530 | Tetragraph Neuromuscular Transmission Monitor | Senzime AB | 2022-08-17 | Traditional | PDF ↗ |
| K220976 | Life Scope PT BSM-1700 Series Bedside Monitor | Nihon Kohden Corporation | 2022-07-21 | Special | PDF ↗ |
| K212434 | Neuromuscular Transmission Monitor TOF3D | MIPM Mammendorfer Institut für Physik und Medizin GmbH | 2022-05-05 | Traditional | PDF ↗ |
| 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 | Special | PDF ↗ |
| K201949 | Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series | Nihon Kohden Corporation | 2021-05-02 | Traditional | PDF ↗ |
| K192958 | TwitchView System | Blink Device Company | 2020-04-02 | Special | PDF ↗ |
| K190795 | Tetragraph Neuromuscular Transmission Monitor | Senzime AB | 2019-10-18 | Traditional | PDF ↗ |
| K172690 | ToFscan | Idmed | 2018-05-31 | Traditional | PDF ↗ |
| K172843 | TwitchView System | Blink Device Corporation | 2018-03-29 | Traditional | PDF ↗ |
| K162048 | EZstim*III Peripheral Nerve Stimulator/Nerve Locator | Halyard Health - Irvine | 2016-12-05 | Traditional | PDF ↗ |
| K051635 | DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES | GE Healthcare | 2005-07-15 | Special | PDF ↗ |
| K042003 | INFINITY TRIDENT NMT POD | Draeger Medical Systems, Inc. | 2004-09-01 | Traditional | PDF ↗ |
| K023342 | NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III NERVE MAPPING PROBE, NEURO-TRACE III NERVE BG | Hdc Corp. | 2004-03-02 | Traditional | PDF ↗ |
| K002889 | PNS MAGNETIC STIMULATOR SYSTEM | Neotonus, Inc. | 2001-04-06 | Traditional | PDF ↗ |
| K992598 | TOF-WATCH SX | Organon Teknika Corp. | 1999-08-30 | Special | PDF ↗ |
| K992596 | TOF-WATCH S | Organon Teknika Corp. | 1999-08-30 | Special | PDF ↗ |
| K972698 | TOF-WATCH | Organon Teknika Corp. | 1997-12-16 | Traditional | PDF ↗ |
| K955026 | AS/3 NMT MODULE | Datex Medical Instrumentation, Inc. | 1997-04-28 | Traditional | PDF ↗ |
| K955031 | MAXISTIM | Life-Tech Intl., Inc. | 1996-12-10 | Traditional | PDF ↗ |
| K954505 | EZ STIM | Life-Tech Intl., Inc. | 1996-12-10 | Traditional | PDF ↗ |
| K953205 | CONSTANT CURRENT PERIPHERAL NERVE STIMULATOR NS272 (MODIFICATION) | Fisher & Paykel Healthcare, Ltd. | 1996-05-23 | Traditional | PDF ↗ |
| K925159 | TOF-GUARD TRANSMISSION MONITOR | Biometer Intl. A/S | 1993-09-01 | Traditional | PDF ↗ |
| K924234 | CONS. CURRENT PERIPH. NERVE LOC. NS232,NS262,NS272 | Fisher & Paykel Electronics , Ltd. | 1993-05-27 | Traditional | PDF ↗ |
| K861091 | EASISTIM | Promed Corp. | 1986-06-02 | Traditional | PDF ↗ |
| K840108 | NEUROMUSCULAR TRANSMISSION MONITOR | Datex Division Instrumentarium Corp. | 1984-02-17 | Traditional | PDF ↗ |
Product code KOI · Class II · Anesthesiology. Data: openFDA.