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)

MISTY-OX PREFILLED HUMIDIFIER, DISP.

K-Number: K781600 · 1978-10-31

ApplicantDavco
Decision Date1978-10-31
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MISTY-OX PREFILLED HUMIDIFIER, DISP. is the device name listed in this FDA 510(k) record. The listed applicant is Davco. It received FDA 510(k) clearance on 1978-10-31 under 510(k) number K781600. 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 MISTY-OX PREFILLED HUMIDIFIER, DISP.?

MISTY-OX PREFILLED HUMIDIFIER, DISP. is a medical device that received FDA 510(k) clearance on 1978-10-31. The listed applicant is Davco. The 510(k) number is K781600.

When did MISTY-OX PREFILLED HUMIDIFIER, DISP. receive FDA 510(k) clearance?

MISTY-OX PREFILLED HUMIDIFIER, DISP. received FDA 510(k) clearance on 1978-10-31, under 510(k) number K781600.

Who is the listed applicant for MISTY-OX PREFILLED HUMIDIFIER, DISP.?

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

What is the FDA product code for MISTY-OX PREFILLED HUMIDIFIER, DISP.?

The FDA product code for MISTY-OX PREFILLED HUMIDIFIER, DISP. 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

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.

↑