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FDA 510(k)

MODEL 9500 MR-COMPATIBLE MULTIGAS MONITOR

K-Number: K954120 · 1997-04-02

ApplicantMagnetic Resonance Equipment Corp.
Decision Date1997-04-02
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODEL 9500 MR-COMPATIBLE MULTIGAS MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Magnetic Resonance Equipment Corp.. It received FDA 510(k) clearance on 1997-04-02 under 510(k) number K954120. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 9500 MR-COMPATIBLE MULTIGAS MONITOR?

MODEL 9500 MR-COMPATIBLE MULTIGAS MONITOR is a medical device that received FDA 510(k) clearance on 1997-04-02. The listed applicant is Magnetic Resonance Equipment Corp.. The 510(k) number is K954120.

When did MODEL 9500 MR-COMPATIBLE MULTIGAS MONITOR receive FDA 510(k) clearance?

MODEL 9500 MR-COMPATIBLE MULTIGAS MONITOR received FDA 510(k) clearance on 1997-04-02, under 510(k) number K954120.

Who is the listed applicant for MODEL 9500 MR-COMPATIBLE MULTIGAS MONITOR?

The FDA 510(k) record lists Magnetic Resonance Equipment Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL 9500 MR-COMPATIBLE MULTIGAS MONITOR?

The FDA product code for MODEL 9500 MR-COMPATIBLE MULTIGAS MONITOR is CCK.

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Other records listing Magnetic Resonance Equipment Corp. 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.

K003982TEMPERATURE FUNCTION, MODEL 9500 MULTIGAS MONITORK983250INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITORK924285MODEL 3500 MR-COMPATIBLE PULSE OXIMETERK924282MODEL 320 MR-COMPATIBLE PULSE OXIMETER

Related Devices (Code: CCK)

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.

K251641GF-310R Multigas Unit (GF-310R)Nihon Kohden CorporationK261633VisuBreathAffirm Medical Technologies II, LLCK253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLCK250148Medical Gas Analyzer (AG200)Prior Care Science Technology, Ltd.K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)Nihon Kohden CorporationK2512160184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling lineBarbaras Development, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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