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FDA 510(k)

THERMIX INC. NASOTHERM II PERSONAL STEAM MACHINE

K-Number: K852283 · 1985-07-30

ApplicantThermix, Inc.
Decision Date1985-07-30
Product CodeKFZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

THERMIX INC. NASOTHERM II PERSONAL STEAM MACHINE is the device name listed in this FDA 510(k) record. The listed applicant is Thermix, Inc.. It received FDA 510(k) clearance on 1985-07-30 under 510(k) number K852283. 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 THERMIX INC. NASOTHERM II PERSONAL STEAM MACHINE?

THERMIX INC. NASOTHERM II PERSONAL STEAM MACHINE is a medical device that received FDA 510(k) clearance on 1985-07-30. The listed applicant is Thermix, Inc.. The 510(k) number is K852283.

When did THERMIX INC. NASOTHERM II PERSONAL STEAM MACHINE receive FDA 510(k) clearance?

THERMIX INC. NASOTHERM II PERSONAL STEAM MACHINE received FDA 510(k) clearance on 1985-07-30, under 510(k) number K852283.

Who is the listed applicant for THERMIX INC. NASOTHERM II PERSONAL STEAM MACHINE?

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

What is the FDA product code for THERMIX INC. NASOTHERM II PERSONAL STEAM MACHINE?

The FDA product code for THERMIX INC. NASOTHERM II PERSONAL STEAM MACHINE is KFZ.

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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

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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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