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FDA 510(k)

Anscare SIMO Negative Pressure Wound Therapy (NPWT) System

K-Number: K193185 · 2020-05-04

Decision Date2020-05-04
Product CodeOKO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Anscare SIMO Negative Pressure Wound Therapy (NPWT) System is a medical device manufactured by Benq Materials Corporation. It received FDA 510(k) clearance on 2020-05-04 under approval number K193185. The device is classified under product code OKO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Anscare SIMO Negative Pressure Wound Therapy (NPWT) System?

Anscare SIMO Negative Pressure Wound Therapy (NPWT) System is a medical device that received FDA 510(k) clearance on 2020-05-04. It is manufactured by Benq Materials Corporation. The 510(k) number is K193185.

When was Anscare SIMO Negative Pressure Wound Therapy (NPWT) System approved by the FDA?

Anscare SIMO Negative Pressure Wound Therapy (NPWT) System received FDA 510(k) clearance on 2020-05-04, under approval number K193185.

What company makes Anscare SIMO Negative Pressure Wound Therapy (NPWT) System?

Anscare SIMO Negative Pressure Wound Therapy (NPWT) System is manufactured by Benq Materials Corporation.

What is the FDA product code for Anscare SIMO Negative Pressure Wound Therapy (NPWT) System?

The FDA product code for Anscare SIMO Negative Pressure Wound Therapy (NPWT) System is OKO.

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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.