FDA 510(k)

ASK-System

K-Nummer: K181146 · 2018-08-03

AntragstellerL and K Biomed Corporation Limited

Entscheidungsdatum2018-08-03

ProduktcodeJWH

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

ASK System is the device name listed in this FDA 510(k) record. The listed applicant is L and K Biomed Corporation Limited. It received FDA 510(k) clearance on 2018-08-03 under 510(k) number K181146. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the ASK System?

ASK System is a medical device that received FDA 510(k) clearance on 2018-08-03. The listed applicant is L and K Biomed Corporation Limited. The 510(k) number is K181146.

When did ASK System receive FDA 510(k) clearance?

ASK System received FDA 510(k) clearance on 2018-08-03, under 510(k) number K181146.

Who is the listed applicant for ASK System?

The FDA 510(k) record lists L and K Biomed Corporation Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASK System?

The FDA product code for ASK System is JWH.

Zugehörige klinische Studien

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Verwandte Geräte (Code: JWH)

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Offizielle Quelle

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