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FDA 510(k)

INFINITY GAMMA

K-Number: K041087 · 2004-05-12

ApplicantDraeger Medical Systems, Inc.
Decision Date2004-05-12
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INFINITY GAMMA 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 2004-05-12 under 510(k) number K041087. 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?

INFINITY GAMMA is a medical device that received FDA 510(k) clearance on 2004-05-12. The listed applicant is Draeger Medical Systems, Inc.. The 510(k) number is K041087.

When did INFINITY GAMMA receive FDA 510(k) clearance?

INFINITY GAMMA received FDA 510(k) clearance on 2004-05-12, under 510(k) number K041087.

Who is the listed applicant for INFINITY GAMMA?

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?

The FDA product code for INFINITY GAMMA is MHX.

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Other records listing Draeger Medical Systems, 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: 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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