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FDA 510(k)

NEBULIZER/HUMIDIFIER MODEL EH 147B

K-Number: K781591 · 1978-10-16

ApplicantMistogen Equipment Co.
Decision Date1978-10-16
Product CodeKFZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NEBULIZER/HUMIDIFIER MODEL EH 147B 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 1978-10-16 under 510(k) number K781591. 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 NEBULIZER/HUMIDIFIER MODEL EH 147B?

NEBULIZER/HUMIDIFIER MODEL EH 147B is a medical device that received FDA 510(k) clearance on 1978-10-16. The listed applicant is Mistogen Equipment Co.. The 510(k) number is K781591.

When did NEBULIZER/HUMIDIFIER MODEL EH 147B receive FDA 510(k) clearance?

NEBULIZER/HUMIDIFIER MODEL EH 147B received FDA 510(k) clearance on 1978-10-16, under 510(k) number K781591.

Who is the listed applicant for NEBULIZER/HUMIDIFIER MODEL EH 147B?

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 NEBULIZER/HUMIDIFIER MODEL EH 147B?

The FDA product code for NEBULIZER/HUMIDIFIER MODEL EH 147B 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 10K770984TA-2 TEMPERATURE ALARMK760341HUMIDIFIER, ELECTRONIC (EH147)

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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