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FDA 510(k)

INFINITY GAMMA / GAMMAXL, INFINITY VISTA

K-Number: K053484 · 2006-02-22

ApplicantDraeger Medical Systems, Inc.
Decision Date2006-02-22
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INFINITY GAMMA / GAMMAXL, INFINITY VISTA is the device name listed in this FDA 510(k) record. The listed applicant is Draeger Medical Systems, Inc.. It received FDA 510(k) clearance on 2006-02-22 under 510(k) number K053484. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFINITY GAMMA / GAMMAXL, INFINITY VISTA?

INFINITY GAMMA / GAMMAXL, INFINITY VISTA is a medical device that received FDA 510(k) clearance on 2006-02-22. The listed applicant is Draeger Medical Systems, Inc.. The 510(k) number is K053484.

When did INFINITY GAMMA / GAMMAXL, INFINITY VISTA receive FDA 510(k) clearance?

INFINITY GAMMA / GAMMAXL, INFINITY VISTA received FDA 510(k) clearance on 2006-02-22, under 510(k) number K053484.

Who is the listed applicant for INFINITY GAMMA / GAMMAXL, INFINITY VISTA?

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

What is the FDA product code for INFINITY GAMMA / GAMMAXL, INFINITY VISTA?

The FDA product code for INFINITY GAMMA / GAMMAXL, INFINITY VISTA is MHX.

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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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