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FDA 510(k)

E-Z-EM ENDOSCOPIC CO2 REGULATOR

K-Number: K053008 · 2005-12-27

ApplicantE-Z-Em, Inc.
Decision Date2005-12-27
Product CodeFCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

E-Z-EM ENDOSCOPIC CO2 REGULATOR 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 2005-12-27 under 510(k) number K053008. The device is classified under product code FCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the E-Z-EM ENDOSCOPIC CO2 REGULATOR?

E-Z-EM ENDOSCOPIC CO2 REGULATOR is a medical device that received FDA 510(k) clearance on 2005-12-27. The listed applicant is E-Z-Em, Inc.. The 510(k) number is K053008.

When did E-Z-EM ENDOSCOPIC CO2 REGULATOR receive FDA 510(k) clearance?

E-Z-EM ENDOSCOPIC CO2 REGULATOR received FDA 510(k) clearance on 2005-12-27, under 510(k) number K053008.

Who is the listed applicant for E-Z-EM ENDOSCOPIC CO2 REGULATOR?

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 E-Z-EM ENDOSCOPIC CO2 REGULATOR?

The FDA product code for E-Z-EM ENDOSCOPIC CO2 REGULATOR is FCX.

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

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Related Devices (Code: FCX)

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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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