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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Blink Device Company. It received FDA 510(k) clearance on 2020-04-02 under 510(k) 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. The listed applicant is Blink Device Company. The 510(k) number is K192958.

When did TwitchView System receive FDA 510(k) clearance?

TwitchView System received FDA 510(k) clearance on 2020-04-02, under 510(k) number K192958.

Who is the listed applicant for TwitchView System?

The FDA 510(k) record lists Blink Device Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TwitchView System?

The FDA product code for TwitchView System is KOI.

Other records listing Blink Device Company as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K172843TwitchView System

Related Devices (Code: KOI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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