FDA 510(k)

OptoMonitor

K-Number: K192340 · 2019-12-12

Decision Date2019-12-12

Product CodeDXO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

OptoMonitor is the device name listed in this FDA 510(k) record. The listed applicant is Opsens, Inc.. It received FDA 510(k) clearance on 2019-12-12 under 510(k) number K192340. The device is classified under product code DXO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OptoMonitor?

OptoMonitor is a medical device that received FDA 510(k) clearance on 2019-12-12. The listed applicant is Opsens, Inc.. The 510(k) number is K192340.

When did OptoMonitor receive FDA 510(k) clearance?

OptoMonitor received FDA 510(k) clearance on 2019-12-12, under 510(k) number K192340.

Who is the listed applicant for OptoMonitor?

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 OptoMonitor?

The FDA product code for OptoMonitor is DXO.

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.

K251367OptoMonitor 3 K241418OptoMonitor 3 K240864PacePro Wire K213854SavvyWire K202943OptoMonitor 3 K193620OptoMonitor 3

View all 10 devices →

Related Devices (Code: DXO)

K251367OptoMonitor 3Opsens, Inc.K241418OptoMonitor 3Opsens, Inc.K233904ACIST RXi System (016616); ACIST Navvus II Catheter (016675_Acist Medical Systems, Inc.K222216TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC K202943OptoMonitor 3Opsens, Inc.K193620OptoMonitor 3Opsens, Inc.

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.