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FDA 510(k)

MEDISONIC OXYGEN FLOW CONTROLLER

K-Number: K923660 · 1993-01-27

ApplicantMedisonic U.S.A., Inc.
Decision Date1993-01-27
Product CodeNFB
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MEDISONIC OXYGEN FLOW CONTROLLER is the device name listed in this FDA 510(k) record. The listed applicant is Medisonic U.S.A., Inc.. It received FDA 510(k) clearance on 1993-01-27 under 510(k) number K923660. The device is classified under product code NFB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDISONIC OXYGEN FLOW CONTROLLER?

MEDISONIC OXYGEN FLOW CONTROLLER is a medical device that received FDA 510(k) clearance on 1993-01-27. The listed applicant is Medisonic U.S.A., Inc.. The 510(k) number is K923660.

When did MEDISONIC OXYGEN FLOW CONTROLLER receive FDA 510(k) clearance?

MEDISONIC OXYGEN FLOW CONTROLLER received FDA 510(k) clearance on 1993-01-27, under 510(k) number K923660.

Who is the listed applicant for MEDISONIC OXYGEN FLOW CONTROLLER?

The FDA 510(k) record lists Medisonic U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDISONIC OXYGEN FLOW CONTROLLER?

The FDA product code for MEDISONIC OXYGEN FLOW CONTROLLER is NFB.

Related Clinical Trials

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Other records listing Medisonic U.S.A., 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.

K924577MEDIVACK901114MEDISONIC HUMDIFIER/INHALERK896192MEDISONIC PNEU-NEBK894961MEDISONIC ULTRA-SONIC INHALER

Related Devices (Code: NFB)

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.

K250322Respond OC Conserving Regulator (130-0800)Responsive RespiratoryK220591ProximaDynasthetics, LLCK221014Effortless Oxygen Conserver System Models Effortless Pro and Effortless MobileEffortless Oxygen, LLCK200401ApogeeIncoba Ltd D/B/A DynarisK151506Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen CannulaSalter LabsK131023THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMENMedical Products, LLC

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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