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FDA 510(k)

THERASTEAM PERSONAL STEAM INHALER

K-Number: K950116 · 1995-02-10

ApplicantKaz, Inc.
Decision Date1995-02-10
Product CodeKFZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

THERASTEAM PERSONAL STEAM INHALER is the device name listed in this FDA 510(k) record. The listed applicant is Kaz, Inc.. It received FDA 510(k) clearance on 1995-02-10 under 510(k) number K950116. 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 THERASTEAM PERSONAL STEAM INHALER?

THERASTEAM PERSONAL STEAM INHALER is a medical device that received FDA 510(k) clearance on 1995-02-10. The listed applicant is Kaz, Inc.. The 510(k) number is K950116.

When did THERASTEAM PERSONAL STEAM INHALER receive FDA 510(k) clearance?

THERASTEAM PERSONAL STEAM INHALER received FDA 510(k) clearance on 1995-02-10, under 510(k) number K950116.

Who is the listed applicant for THERASTEAM PERSONAL STEAM INHALER?

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

What is the FDA product code for THERASTEAM PERSONAL STEAM INHALER?

The FDA product code for THERASTEAM PERSONAL STEAM INHALER is KFZ.

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Other records listing Kaz, 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.

K103839BEHIND EAR GENTLE TOUCH THERMOMETER

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.

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.K862171MP-500 ELECTRONIC NEBULIZERThe Timeter Group

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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