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FDA 510(k)

PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM

K-Number: K983314 · 1999-02-19

ApplicantNycomed Amersham Imaging
Decision Date1999-02-19
Product CodeIZQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nycomed Amersham Imaging. It received FDA 510(k) clearance on 1999-02-19 under 510(k) number K983314. The device is classified under product code IZQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM?

PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 1999-02-19. The listed applicant is Nycomed Amersham Imaging. The 510(k) number is K983314.

When did PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM receive FDA 510(k) clearance?

PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM received FDA 510(k) clearance on 1999-02-19, under 510(k) number K983314.

Who is the listed applicant for PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM?

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

What is the FDA product code for PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM?

The FDA product code for PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM is IZQ.

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Related Devices (Code: IZQ)

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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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