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FDA 510(k)

AIR OXYGE MIXER

K-Number: K974372 · 1998-02-05

ApplicantSk Med
Decision Date1998-02-05
Product CodeBZR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AIR OXYGE MIXER is the device name listed in this FDA 510(k) record. The listed applicant is Sk Med. It received FDA 510(k) clearance on 1998-02-05 under 510(k) number K974372. The device is classified under product code BZR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIR OXYGE MIXER?

AIR OXYGE MIXER is a medical device that received FDA 510(k) clearance on 1998-02-05. The listed applicant is Sk Med. The 510(k) number is K974372.

When did AIR OXYGE MIXER receive FDA 510(k) clearance?

AIR OXYGE MIXER received FDA 510(k) clearance on 1998-02-05, under 510(k) number K974372.

Who is the listed applicant for AIR OXYGE MIXER?

The FDA 510(k) record lists Sk Med as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AIR OXYGE MIXER?

The FDA product code for AIR OXYGE MIXER is BZR.

Related Clinical Trials

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Other records listing Sk Med 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.

K031860SK MED ME202 MONITORING MIXERK031707SK MED M201 PLUS MIXERK022864SK MED M201 MIXER

Related Devices (Code: BZR)

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.

K243917F&P Optiflow Air/Oxygen Flow SourceFisher & Paykel Healthcare, Ltd.K241465Midas Flowmeter; eAVSParker Hannifin CorporationK231895Maxtec MaxBlend2+pMaxtec, LLCK230987FlowStar Analog Mixer FlowmeterBaldus Sedation GmbH & Co. KGK222794FlowStar Touch Digital Mixer FlowmeterBaldus Sedation GmbH & Co. KGK221494Quality Mix Blender, OxymixerDehas Medical Systems GmbH

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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