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)

MODELS MR410 & MR480 RESPIRATORY HUMIDIFIER/ACCESS

K-Number: K913367 · 1992-06-25

ApplicantFisher & Paykel Electronics , Ltd.
Decision Date1992-06-25
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODELS MR410 & MR480 RESPIRATORY HUMIDIFIER/ACCESS is the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Electronics , Ltd.. It received FDA 510(k) clearance on 1992-06-25 under 510(k) number K913367. 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 MODELS MR410 & MR480 RESPIRATORY HUMIDIFIER/ACCESS?

MODELS MR410 & MR480 RESPIRATORY HUMIDIFIER/ACCESS is a medical device that received FDA 510(k) clearance on 1992-06-25. The listed applicant is Fisher & Paykel Electronics , Ltd.. The 510(k) number is K913367.

When did MODELS MR410 & MR480 RESPIRATORY HUMIDIFIER/ACCESS receive FDA 510(k) clearance?

MODELS MR410 & MR480 RESPIRATORY HUMIDIFIER/ACCESS received FDA 510(k) clearance on 1992-06-25, under 510(k) number K913367.

Who is the listed applicant for MODELS MR410 & MR480 RESPIRATORY HUMIDIFIER/ACCESS?

The FDA 510(k) record lists Fisher & Paykel Electronics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODELS MR410 & MR480 RESPIRATORY HUMIDIFIER/ACCESS?

The FDA product code for MODELS MR410 & MR480 RESPIRATORY HUMIDIFIER/ACCESS 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 Fisher & Paykel Electronics , Ltd. 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.

K973161CPAP HUMIDIFIER (HC 200)K972885SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, MANUAL CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW970K971695SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMERK971461SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL WALL-MOUNT INFANT WARMER(IW990)K970432INFANT RADIANT WARMER - MODELS IW910 AND IW920K953392HC500 SERVO-CONTROLLED HEATED RESPIRATORY HUMIDIFIER (& ACCESSORIES)

View all 17 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.

↑