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

FDA 510(k)

FloSure Ventilation Patch

K-Number: K150459 · 2016-01-05

ApplicantSimex Medizintechnik GmbH
Decision Date2016-01-05
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FloSure Ventilation Patch is a medical device manufactured by Simex Medizintechnik GmbH. It received FDA 510(k) clearance on 2016-01-05 under approval number K150459. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FloSure Ventilation Patch?

FloSure Ventilation Patch is a medical device that received FDA 510(k) clearance on 2016-01-05. It is manufactured by Simex Medizintechnik GmbH. The 510(k) number is K150459.

When was FloSure Ventilation Patch approved by the FDA?

FloSure Ventilation Patch received FDA 510(k) clearance on 2016-01-05, under approval number K150459.

What company makes FloSure Ventilation Patch?

FloSure Ventilation Patch is manufactured by Simex Medizintechnik GmbH.

What is the FDA product code for FloSure Ventilation Patch?

The FDA product code for FloSure Ventilation Patch is OMP.

Related Devices (Code: OMP)

K160487V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) SystemKci USA, Inc. K161128Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power SupplyMedela AG K150960WoundPro Negative Pressure Wound Therapy SystemPensar Medical, LLC K161935Avance Foam Dressing Kit - XLMolnlycke Health Care Us, LLC K161948Avance Gauze Dressing KitsMolnlycke Health Care Us, LLC K161797Avance Tubing, Avance Y-Connector, Avance ViewPadMolnlycke Health Care Us, LLC

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.

↑