FDA 510(k)

DUAL SHOT ALPHA

K-Number: K071691 · 2007-12-19

Decision Date2007-12-19

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

DUAL SHOT ALPHA 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 2007-12-19 under 510(k) number K071691. 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 DUAL SHOT ALPHA?

DUAL SHOT ALPHA is a medical device that received FDA 510(k) clearance on 2007-12-19. The listed applicant is Nemoto Kyorindo Co., Ltd.. The 510(k) number is K071691.

When did DUAL SHOT ALPHA receive FDA 510(k) clearance?

DUAL SHOT ALPHA received FDA 510(k) clearance on 2007-12-19, under 510(k) number K071691.

Who is the listed applicant for DUAL SHOT ALPHA?

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 DUAL SHOT ALPHA?

The FDA product code for DUAL SHOT ALPHA is DXT.

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

K242212Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)K173450PRESS DUO elite, PRESS DUO elite AG K092896REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS K091734SONIC SHOT GX K062168CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA K052633DUAL SHOT - CONTRAST DELIVERY SYSTEM

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.