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FDA 510(k)

EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825

K-Number: K031571 · 2003-06-19

ApplicantE-Z-Em, Inc.
Decision Date2003-06-19
Product CodeIZQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 is the device name listed in this FDA 510(k) record. The listed applicant is E-Z-Em, Inc.. It received FDA 510(k) clearance on 2003-06-19 under 510(k) number K031571. 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 EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825?

EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 is a medical device that received FDA 510(k) clearance on 2003-06-19. The listed applicant is E-Z-Em, Inc.. The 510(k) number is K031571.

When did EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 receive FDA 510(k) clearance?

EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 received FDA 510(k) clearance on 2003-06-19, under 510(k) number K031571.

Who is the listed applicant for EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825?

The FDA 510(k) record lists E-Z-Em, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825?

The FDA product code for EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 is IZQ.

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Other records listing E-Z-Em, Inc. 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.

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Related Devices (Code: IZQ)

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.

K262115VueJect® Ultrasound Enhancing Agent Delivery SystemACIST Medical Systems, Inc.K252281ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)Ulrich GmbH & Co. KGK251295ulrichINJECT CT Motion (XD 8000)Ulrich GmbH & Co. KGK252689MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)Imaxeon Pty, Ltd.K241849MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)Imaxeon Pty, Ltd.K241850ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)Ulrich GmbH & Co. KG

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.

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