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FDA 510(k)

INFINITY KAPPA XLT

K-Number: K042904 · 2005-02-18

ApplicantDraeger Medical Systems, Inc.
Decision Date2005-02-18
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INFINITY KAPPA XLT 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 2005-02-18 under 510(k) number K042904. 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 KAPPA XLT?

INFINITY KAPPA XLT is a medical device that received FDA 510(k) clearance on 2005-02-18. The listed applicant is Draeger Medical Systems, Inc.. The 510(k) number is K042904.

When did INFINITY KAPPA XLT receive FDA 510(k) clearance?

INFINITY KAPPA XLT received FDA 510(k) clearance on 2005-02-18, under 510(k) number K042904.

Who is the listed applicant for INFINITY KAPPA XLT?

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 KAPPA XLT?

The FDA product code for INFINITY KAPPA XLT is MHX.

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Other records listing Draeger Medical Systems, Inc. as applicant

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Related Devices (Code: MHX)

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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