Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

O2Vent Optima

K-Number: K190236 · 2019-08-29

ApplicantOventus Manufacturing Pty, Ltd.
Decision Date2019-08-29
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

O2Vent Optima is the device name listed in this FDA 510(k) record. The listed applicant is Oventus Manufacturing Pty, Ltd.. It received FDA 510(k) clearance on 2019-08-29 under 510(k) number K190236. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the O2Vent Optima?

O2Vent Optima is a medical device that received FDA 510(k) clearance on 2019-08-29. The listed applicant is Oventus Manufacturing Pty, Ltd.. The 510(k) number is K190236.

When did O2Vent Optima receive FDA 510(k) clearance?

O2Vent Optima received FDA 510(k) clearance on 2019-08-29, under 510(k) number K190236.

Who is the listed applicant for O2Vent Optima?

The FDA 510(k) record lists Oventus Manufacturing Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for O2Vent Optima?

The FDA product code for O2Vent Optima is LRK.

Other records listing Oventus Manufacturing Pty, Ltd. 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.

K171316O2Vent WK161832O2VENT TK160234OVENT

Related Devices (Code: LRK)

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.

K261912SnØreNegatØrDnB Innovations, LLCK261366VirtusSomnomed, Inc.K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLCK261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.K252942ShaeferHShaeferh, LLCK253845Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)Ram.Shaw Pte. , Ltd.

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.

↑