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FDA 510(k)

SONIC MIST ULTRASONIC HUMIDIFIER

K-Number: K831646 · 1983-07-12

ApplicantDouglas Products
Decision Date1983-07-12
Product CodeKFZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SONIC MIST ULTRASONIC HUMIDIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Douglas Products. It received FDA 510(k) clearance on 1983-07-12 under 510(k) number K831646. 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 SONIC MIST ULTRASONIC HUMIDIFIER?

SONIC MIST ULTRASONIC HUMIDIFIER is a medical device that received FDA 510(k) clearance on 1983-07-12. The listed applicant is Douglas Products. The 510(k) number is K831646.

When did SONIC MIST ULTRASONIC HUMIDIFIER receive FDA 510(k) clearance?

SONIC MIST ULTRASONIC HUMIDIFIER received FDA 510(k) clearance on 1983-07-12, under 510(k) number K831646.

Who is the listed applicant for SONIC MIST ULTRASONIC HUMIDIFIER?

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

What is the FDA product code for SONIC MIST ULTRASONIC HUMIDIFIER?

The FDA product code for SONIC MIST ULTRASONIC HUMIDIFIER 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

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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