FDA 510(k)

Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)

K-Nummer: K242212 · 2024-08-27

Entscheidungsdatum2024-08-27

ProduktcodeDXT

BeratungsausschussCV

EntscheidungSubstantially Equivalent

Produktübersicht

Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) is the device name listed in this FDA 510(k) record. The listed applicant is Nemoto Kyorindo Co., Ltd.. It received FDA 510(k) clearance on 2024-08-27 under 510(k) number K242212. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)?

Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) is a medical device that received FDA 510(k) clearance on 2024-08-27. The listed applicant is Nemoto Kyorindo Co., Ltd.. The 510(k) number is K242212.

When did Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) receive FDA 510(k) clearance?

Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) received FDA 510(k) clearance on 2024-08-27, under 510(k) number K242212.

Who is the listed applicant for Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)?

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

What is the FDA product code for Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)?

The FDA product code for Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) is DXT.

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Weitere Einträge mit Nemoto Kyorindo Co., Ltd. als Antragsteller

K173450PRESS DUO elite, PRESS DUO elite AG

Verwandte Geräte (Code: DXT)

K252652Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable SyrFortis Biosolutions Company Limited K252653ACIST Pro Diagnosesystem (019304); Verarbeitungseinheit Bettmontage; AngioTouch Modul; ACIST Pro Wagen; Einzelsensorkabel; DreibandsensorkabelAcist Medical Systems, Inc.K252638VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804)Acist Medical Systems, Inc.K253048High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer TubeShenzhen Maiwei Biotech Co., Ltd.K251788Extension tubeZhuhai DR Medical Instruments Co., Ltd.K252891MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)Bayer Medical Care, Inc.

Offizielle Quelle

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