OptoMonitor 3
K-Number: K193620 · 2020-06-18
ApplicantOpsens, Inc.
Decision Date2020-06-18
Product CodeDXO
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
OptoMonitor 3 is a medical device manufactured by Opsens, Inc.. It received FDA 510(k) clearance on 2020-06-18 under approval number K193620. 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 3?
OptoMonitor 3 is a medical device that received FDA 510(k) clearance on 2020-06-18. It is manufactured by Opsens, Inc.. The 510(k) number is K193620.
When was OptoMonitor 3 approved by the FDA?
OptoMonitor 3 received FDA 510(k) clearance on 2020-06-18, under approval number K193620.
What company makes OptoMonitor 3?
OptoMonitor 3 is manufactured by Opsens, Inc..
What is the FDA product code for OptoMonitor 3?
The FDA product code for OptoMonitor 3 is DXO.
Other Devices by Opsens, Inc.
Related Devices (Code: DXO)
K161263OptoMonitor IIOpsens, Inc.
K161171PressureWire X GuidewireSt. Jude Medical, Inc.
K171996TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC
K163376Mikro-Cath Pressure CatheterMillar, Inc.
K180558PressureWire XSt. Jude Medical (Now Part of Abbott Medical)
K193279Comet II Pressure GuidewireBoston Scientific 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.