TwitchView System
K-Number: K192958 · 2020-04-02
ApplicantBlink Device Company
Decision Date2020-04-02
Product CodeKOI
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
TwitchView System is a medical device manufactured by Blink Device Company. It received FDA 510(k) clearance on 2020-04-02 under approval number K192958. The device is classified under product code KOI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TwitchView System?
TwitchView System is a medical device that received FDA 510(k) clearance on 2020-04-02. It is manufactured by Blink Device Company. The 510(k) number is K192958.
When was TwitchView System approved by the FDA?
TwitchView System received FDA 510(k) clearance on 2020-04-02, under approval number K192958.
What company makes TwitchView System?
TwitchView System is manufactured by Blink Device Company.
What is the FDA product code for TwitchView System?
The FDA product code for TwitchView System is KOI.
Related Devices (Code: KOI)
K162048EZstim*III Peripheral Nerve Stimulator/Nerve LocatorHalyard Health - Irvine
K172690ToFscanIdmed
K172843TwitchView SystemBlink Device Corporation
K190795Tetragraph Neuromuscular Transmission MonitorSenzime AB
K213316Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEMNihon Kohden Corporation
K201949Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 SeriesNihon Kohden Corporation
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.