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FDA 510(k)

EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900

K-Number: K063029 · 2006-11-02

ApplicantE-Z-Em, Inc.
Decision Date2006-11-02
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900 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 2006-11-02 under 510(k) number K063029. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900?

EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900 is a medical device that received FDA 510(k) clearance on 2006-11-02. The listed applicant is E-Z-Em, Inc.. The 510(k) number is K063029.

When did EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900 receive FDA 510(k) clearance?

EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900 received FDA 510(k) clearance on 2006-11-02, under 510(k) number K063029.

Who is the listed applicant for EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900?

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 EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900?

The FDA product code for EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900 is JAK.

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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.

K071378MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIESK062449EMPOWERMR INJECTOR SYSTEM, MODEL 9730K053008E-Z-EM ENDOSCOPIC CO2 REGULATORK041178EMPOWER TRANSFER SET, (CAT. NO. 7725)K031571EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825K030854PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400

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Related Devices (Code: JAK)

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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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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