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FDA 510(k)

HUMIDIFIER, ELECTRONIC (EH147)

K-Number: K760341 · 1976-08-11

ApplicantMistogen Equipment Co.
Decision Date1976-08-11
Product CodeKFZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HUMIDIFIER, ELECTRONIC (EH147) is the device name listed in this FDA 510(k) record. The listed applicant is Mistogen Equipment Co.. It received FDA 510(k) clearance on 1976-08-11 under 510(k) number K760341. 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 HUMIDIFIER, ELECTRONIC (EH147)?

HUMIDIFIER, ELECTRONIC (EH147) is a medical device that received FDA 510(k) clearance on 1976-08-11. The listed applicant is Mistogen Equipment Co.. The 510(k) number is K760341.

When did HUMIDIFIER, ELECTRONIC (EH147) receive FDA 510(k) clearance?

HUMIDIFIER, ELECTRONIC (EH147) received FDA 510(k) clearance on 1976-08-11, under 510(k) number K760341.

Who is the listed applicant for HUMIDIFIER, ELECTRONIC (EH147)?

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

What is the FDA product code for HUMIDIFIER, ELECTRONIC (EH147)?

The FDA product code for HUMIDIFIER, ELECTRONIC (EH147) 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Mistogen Equipment Co. 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.

K801619MIST2GEN TEMPTROL 10K781591NEBULIZER/HUMIDIFIER MODEL EH 147BK770984TA-2 TEMPERATURE ALARM

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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