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FDA 510(k)

PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY

K-Number: K020700 · 2004-04-26

ApplicantPegasus Research Corp.
Decision Date2004-04-26
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY 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 2004-04-26 under 510(k) number K020700. 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 PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY?

PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY is a medical device that received FDA 510(k) clearance on 2004-04-26. The listed applicant is Pegasus Research Corp.. The 510(k) number is K020700.

When did PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY receive FDA 510(k) clearance?

PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY received FDA 510(k) clearance on 2004-04-26, under 510(k) number K020700.

Who is the listed applicant for PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY?

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 PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY?

The FDA product code for PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY is BTT.

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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-3100K013856PMH 1000 HEATED HUMIDIFIERK983783HEATED HUMIDIFIERK962534THERA-MIST NEBULIZER MODEL-P3000K946057AQUALARM MOISTURE SENSOR MODEL P85000K915890AUTOCLAVABLE THERA-MIST HUMIDIFIER P3600, MODIFIED

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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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