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FDA 510(k)

INFINITY GAMMA/GAMMAXL AND VISTA WITH VF5

K-Number: K042656 · 2004-10-06

ApplicantDraeger Medical Systems, Inc.
Decision Date2004-10-06
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INFINITY GAMMA/GAMMAXL AND VISTA WITH VF5 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 2004-10-06 under 510(k) number K042656. 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 AND VISTA WITH VF5?

INFINITY GAMMA/GAMMAXL AND VISTA WITH VF5 is a medical device that received FDA 510(k) clearance on 2004-10-06. The listed applicant is Draeger Medical Systems, Inc.. The 510(k) number is K042656.

When did INFINITY GAMMA/GAMMAXL AND VISTA WITH VF5 receive FDA 510(k) clearance?

INFINITY GAMMA/GAMMAXL AND VISTA WITH VF5 received FDA 510(k) clearance on 2004-10-06, under 510(k) number K042656.

Who is the listed applicant for INFINITY GAMMA/GAMMAXL AND VISTA WITH VF5?

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 AND VISTA WITH VF5?

The FDA product code for INFINITY GAMMA/GAMMAXL AND VISTA WITH VF5 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.

K260579Infinity® Acute Care System (IACS) – VG8.1K243606Babyroo TN300K240312Infinity CentralStation WideK233834Infinity Gateway SuiteK231477Infinity CentralStation Wide, Infinity M300, Infinity M300+K230278Babyroo TN300

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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.

K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0MGE Healthcare Finland OyK260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland OyK260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.K254209Radius VSM and AccessoriesMasimo Corporation

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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