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FDA 510(k)

HEATED RESPIRATORY HUMIDIFIER HC100

K-Number: K915460 · 1993-01-15

ApplicantFisher & Paykel Electronics , Ltd.
Decision Date1993-01-15
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HEATED RESPIRATORY HUMIDIFIER HC100 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 1993-01-15 under 510(k) number K915460. 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 HC100?

HEATED RESPIRATORY HUMIDIFIER HC100 is a medical device that received FDA 510(k) clearance on 1993-01-15. The listed applicant is Fisher & Paykel Electronics , Ltd.. The 510(k) number is K915460.

When did HEATED RESPIRATORY HUMIDIFIER HC100 receive FDA 510(k) clearance?

HEATED RESPIRATORY HUMIDIFIER HC100 received FDA 510(k) clearance on 1993-01-15, under 510(k) number K915460.

Who is the listed applicant for HEATED RESPIRATORY HUMIDIFIER HC100?

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 HEATED RESPIRATORY HUMIDIFIER HC100?

The FDA product code for HEATED RESPIRATORY HUMIDIFIER HC100 is BTT.

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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.

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