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FDA 510(k)

ARGES IMAGING CONTRAST SPRAY

K-Number: K113263 · 2011-11-14

ApplicantArges Imaging, Inc.
Decision Date2011-11-14
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ARGES IMAGING CONTRAST SPRAY is the device name listed in this FDA 510(k) record. The listed applicant is Arges Imaging, Inc.. It received FDA 510(k) clearance on 2011-11-14 under 510(k) number K113263. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARGES IMAGING CONTRAST SPRAY?

ARGES IMAGING CONTRAST SPRAY is a medical device that received FDA 510(k) clearance on 2011-11-14. The listed applicant is Arges Imaging, Inc.. The 510(k) number is K113263.

When did ARGES IMAGING CONTRAST SPRAY receive FDA 510(k) clearance?

ARGES IMAGING CONTRAST SPRAY received FDA 510(k) clearance on 2011-11-14, under 510(k) number K113263.

Who is the listed applicant for ARGES IMAGING CONTRAST SPRAY?

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

What is the FDA product code for ARGES IMAGING CONTRAST SPRAY?

The FDA product code for ARGES IMAGING CONTRAST SPRAY is ELW.

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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.

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