FDA 510(k)

FloSure Ventilation Patch

K-Number: K150459 · 2016-01-05

Decision Date2016-01-05

Product CodeOMP

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

FloSure Ventilation Patch is the device name listed in this FDA 510(k) record. The listed applicant is Simex Medizintechnik GmbH. It received FDA 510(k) clearance on 2016-01-05 under 510(k) 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. The listed applicant is Simex Medizintechnik GmbH. The 510(k) number is K150459.

When did FloSure Ventilation Patch receive FDA 510(k) clearance?

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

Who is the listed applicant for FloSure Ventilation Patch?

The FDA 510(k) record lists Simex Medizintechnik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FloSure Ventilation Patch?

The FDA product code for FloSure Ventilation Patch is OMP.

Related Devices (Code: OMP)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.