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FDA 510(k)

HEATED RESPIRATORY HUMIDIFIER MR428

K-Number: K843903 · 1984-10-22

ApplicantFisher & Paykel Allied Products , Ltd.
Decision Date1984-10-22
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HEATED RESPIRATORY HUMIDIFIER MR428 is the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Allied Products , Ltd.. It received FDA 510(k) clearance on 1984-10-22 under 510(k) number K843903. 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 HEATED RESPIRATORY HUMIDIFIER MR428?

HEATED RESPIRATORY HUMIDIFIER MR428 is a medical device that received FDA 510(k) clearance on 1984-10-22. The listed applicant is Fisher & Paykel Allied Products , Ltd.. The 510(k) number is K843903.

When did HEATED RESPIRATORY HUMIDIFIER MR428 receive FDA 510(k) clearance?

HEATED RESPIRATORY HUMIDIFIER MR428 received FDA 510(k) clearance on 1984-10-22, under 510(k) number K843903.

Who is the listed applicant for HEATED RESPIRATORY HUMIDIFIER MR428?

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

What is the FDA product code for HEATED RESPIRATORY HUMIDIFIER MR428?

The FDA product code for HEATED RESPIRATORY HUMIDIFIER MR428 is BTT.

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Other records listing Fisher & Paykel Allied Products , 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.

K880702MODEL MR430 SPECIAL PURPOSE HUMID. HEATER BASESK872138MR630 ENHANCED DUAL SERVO HEATER HUMIDIFIERK872139MR420 TRANSPORT HUMIDIFIERK863377MR338 SERVO HEATED DELIVERY HUMIDIFIERK870055MR590 DUAL HOSE HEATER POWER PACKK862923MR620 DUAL SERVO HEATED ANAESTHESIA HUMIDIFIER

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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.

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