FDA 510(k)

ネクサネガティブプレッシャーワウンドセラピーシステム

K番号: K162610 · 2017-06-08

決定日2017-06-08

製品コードOMP

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

NEXA Negative Pressure Wound Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Nexa Medical , Ltd.. It received FDA 510(k) clearance on 2017-06-08 under 510(k) number K162610. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the NEXA Negative Pressure Wound Therapy System?

NEXA Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2017-06-08. The listed applicant is Nexa Medical , Ltd.. The 510(k) number is K162610.

When did NEXA Negative Pressure Wound Therapy System receive FDA 510(k) clearance?

NEXA Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2017-06-08, under 510(k) number K162610.

Who is the listed applicant for NEXA Negative Pressure Wound Therapy System?

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

What is the FDA product code for NEXA Negative Pressure Wound Therapy System?

The FDA product code for NEXA Negative Pressure Wound Therapy System is OMP.

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ネクサネガティブプレッシャーワウンドセラピーシステム

医療機器の概要

よくある質問

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