FDA 510(k)

CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA

K-Number: K062168 · 2006-08-18

Decision Date2006-08-18

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CONTRAST DELIVERY SYSTEM - 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 2006-08-18 under 510(k) number K062168. 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 CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA?

CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA is a medical device that received FDA 510(k) clearance on 2006-08-18. The listed applicant is Nemoto Kyorindo Co., Ltd.. The 510(k) number is K062168.

When did CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA receive FDA 510(k) clearance?

CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA received FDA 510(k) clearance on 2006-08-18, under 510(k) number K062168.

Who is the listed applicant for CONTRAST DELIVERY SYSTEM - 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 CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA?

The FDA product code for CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA is DXT.

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

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Related Devices (Code: DXT)

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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.