Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

THERA-MIST HUMIDIFIER

K-Number: K894000 · 1989-08-28

ApplicantPegasus Research Corp.
Decision Date1989-08-28
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

THERA-MIST HUMIDIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Pegasus Research Corp.. It received FDA 510(k) clearance on 1989-08-28 under 510(k) number K894000. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERA-MIST HUMIDIFIER?

THERA-MIST HUMIDIFIER is a medical device that received FDA 510(k) clearance on 1989-08-28. The listed applicant is Pegasus Research Corp.. The 510(k) number is K894000.

When did THERA-MIST HUMIDIFIER receive FDA 510(k) clearance?

THERA-MIST HUMIDIFIER received FDA 510(k) clearance on 1989-08-28, under 510(k) number K894000.

Who is the listed applicant for THERA-MIST HUMIDIFIER?

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

What is the FDA product code for THERA-MIST HUMIDIFIER?

The FDA product code for THERA-MIST HUMIDIFIER is BTT.

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 Pegasus Research Corp. 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.

K122857HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100K020700PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPYK013856PMH 1000 HEATED HUMIDIFIERK983783HEATED HUMIDIFIERK962534THERA-MIST NEBULIZER MODEL-P3000K946057AQUALARM MOISTURE SENSOR MODEL P85000

View all 12 devices →

Related Devices (Code: BTT)

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.

K262268Optiflow Oxygen Kit (AA484J)Fisher and Paykel Healthcare LimitedK254078HVT 2.0Vapotherm, Inc.K251448FL-10000U Respiratory HumidifierFlexicare Medical Limited.K251419Laboratorios Biogalenic Sterile Water for Inhalation, USPLaboratorios Biogalenic S.A. DE C.V.K253479Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)Fisher & Paykel Healthcare, Ltd.K250312Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra SmallMedline Industries, LP

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.

↑