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FDA 510(k)

INHALATION THERAPY NEBULIZER DEVICE

K-Number: K850711 · 1985-06-05

ApplicantMed USA
Decision Date1985-06-05
Product CodeKFZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INHALATION THERAPY NEBULIZER DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Med USA. It received FDA 510(k) clearance on 1985-06-05 under 510(k) number K850711. The device is classified under product code KFZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INHALATION THERAPY NEBULIZER DEVICE?

INHALATION THERAPY NEBULIZER DEVICE is a medical device that received FDA 510(k) clearance on 1985-06-05. The listed applicant is Med USA. The 510(k) number is K850711.

When did INHALATION THERAPY NEBULIZER DEVICE receive FDA 510(k) clearance?

INHALATION THERAPY NEBULIZER DEVICE received FDA 510(k) clearance on 1985-06-05, under 510(k) number K850711.

Who is the listed applicant for INHALATION THERAPY NEBULIZER DEVICE?

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

What is the FDA product code for INHALATION THERAPY NEBULIZER DEVICE?

The FDA product code for INHALATION THERAPY NEBULIZER DEVICE is KFZ.

Related Clinical Trials

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.

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Other records listing Med USA 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.

K896766TD-28 DISPOSABLE ELECTRODEK862047COAGULATOR (8 CHANNEL)K852492COAGULATORK841803A1 SYSTEME 8201/2

Related Devices (Code: KFZ)

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.

K950116THERASTEAM PERSONAL STEAM INHALERKaz, Inc.K915603VIROTHERM HUMIDIFIERVirotherm LaboratoryK894734RHINOTHERM ULTRA 2Twinmed Products, Inc.K871661WH150 ROOM HUMIDIFIERAssociated Mills, Inc.K871189SUNBEAM DURA-VAP WARM STEAM VAPORIZER MODEL 1380Sunbeam Appliance Service Co.K862919TRANSPIRATOR(TM) MT-1000 PERSONAL HUMIDIFIERTranspirator Technologics, Inc.

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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