FDA 510(k)

Easydrip Pen Needle, Easydrip Plus Pen Needle

K-Nummer: K193422 · 2021-02-02

AntragstellerSandstone Medical (Suzhou), Inc.

Entscheidungsdatum2021-02-02

ProduktcodeFMI

BeratungsausschussHO

EntscheidungSubstantially Equivalent

Produktübersicht

Easydrip Pen Needle, Easydrip Plus Pen Needle is the device name listed in this FDA 510(k) record. The listed applicant is Sandstone Medical (Suzhou), Inc.. It received FDA 510(k) clearance on 2021-02-02 under 510(k) number K193422. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Easydrip Pen Needle, Easydrip Plus Pen Needle?

Easydrip Pen Needle, Easydrip Plus Pen Needle is a medical device that received FDA 510(k) clearance on 2021-02-02. The listed applicant is Sandstone Medical (Suzhou), Inc.. The 510(k) number is K193422.

When did Easydrip Pen Needle, Easydrip Plus Pen Needle receive FDA 510(k) clearance?

Easydrip Pen Needle, Easydrip Plus Pen Needle received FDA 510(k) clearance on 2021-02-02, under 510(k) number K193422.

Who is the listed applicant for Easydrip Pen Needle, Easydrip Plus Pen Needle?

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

What is the FDA product code for Easydrip Pen Needle, Easydrip Plus Pen Needle?

The FDA product code for Easydrip Pen Needle, Easydrip Plus Pen Needle is FMI.

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Weitere Einträge mit Sandstone Medical (Suzhou), Inc. als Antragsteller

K252908Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle K210864Safety Pen Needle

Verwandte Geräte (Code: FMI)

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHD K261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.

Offizielle Quelle

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