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FDA 510(k)

PRESS DUO elite, PRESS DUO elite AG

K-Number: K173450 · 2018-02-07

ApplicantNemoto Kyorindo Co., Ltd.
Decision Date2018-02-07
Product CodeDXT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRESS DUO elite, PRESS DUO elite AG 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 2018-02-07 under 510(k) number K173450. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRESS DUO elite, PRESS DUO elite AG?

PRESS DUO elite, PRESS DUO elite AG is a medical device that received FDA 510(k) clearance on 2018-02-07. The listed applicant is Nemoto Kyorindo Co., Ltd.. The 510(k) number is K173450.

When did PRESS DUO elite, PRESS DUO elite AG receive FDA 510(k) clearance?

PRESS DUO elite, PRESS DUO elite AG received FDA 510(k) clearance on 2018-02-07, under 510(k) number K173450.

Who is the listed applicant for PRESS DUO elite, PRESS DUO elite AG?

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 PRESS DUO elite, PRESS DUO elite AG?

The FDA product code for PRESS DUO elite, PRESS DUO elite AG is DXT.

Other records listing Nemoto Kyorindo Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242212Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)

Related Devices (Code: DXT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 LimitedK252653ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer CableAcist 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.

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.

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