FDA 510(k)

OptoWire III

K-Number: K191907 · 2020-01-02

Decision Date2020-01-02

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

OptoWire III is the device name listed in this FDA 510(k) record. The listed applicant is Opsens, Inc.. It received FDA 510(k) clearance on 2020-01-02 under 510(k) number K191907. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OptoWire III?

OptoWire III is a medical device that received FDA 510(k) clearance on 2020-01-02. The listed applicant is Opsens, Inc.. The 510(k) number is K191907.

When did OptoWire III receive FDA 510(k) clearance?

OptoWire III received FDA 510(k) clearance on 2020-01-02, under 510(k) number K191907.

Who is the listed applicant for OptoWire III?

The FDA 510(k) record lists Opsens, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OptoWire III?

The FDA product code for OptoWire III is DQX.

Other records listing Opsens, Inc. 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.

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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.