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FDA 510(k)

THE M100 AIR/OXYGEN MIXER

K-Number: K860373 · 1986-05-21

ApplicantNewport Medical Instruments, Inc.
Decision Date1986-05-21
Product CodeBZR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

THE M100 AIR/OXYGEN MIXER is the device name listed in this FDA 510(k) record. The listed applicant is Newport Medical Instruments, Inc.. It received FDA 510(k) clearance on 1986-05-21 under 510(k) number K860373. 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 THE M100 AIR/OXYGEN MIXER?

THE M100 AIR/OXYGEN MIXER is a medical device that received FDA 510(k) clearance on 1986-05-21. The listed applicant is Newport Medical Instruments, Inc.. The 510(k) number is K860373.

When did THE M100 AIR/OXYGEN MIXER receive FDA 510(k) clearance?

THE M100 AIR/OXYGEN MIXER received FDA 510(k) clearance on 1986-05-21, under 510(k) number K860373.

Who is the listed applicant for THE M100 AIR/OXYGEN MIXER?

The FDA 510(k) record lists Newport Medical Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE M100 AIR/OXYGEN MIXER?

The FDA product code for THE M100 AIR/OXYGEN MIXER is BZR.

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Other records listing Newport Medical Instruments, 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.

K121891NEWPORT AURA VENTILATORK111146NEWPORT HT70 VENTILATORK101803NEWPORT E360 VENTILATORK090888NEWPORT HT70 FAMILY OF VENTILATORSK082724NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEMK061094NEWPORT E500 WAVE VENTILATOR

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Related Devices (Code: BZR)

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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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