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FDA 510(k)

NEBULIZER/HUMIDIFIER

K-Number: K781537 · 1978-10-10

ApplicantChemetron Medical Products, Inc.
Decision Date1978-10-10
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NEBULIZER/HUMIDIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Chemetron Medical Products, Inc.. It received FDA 510(k) clearance on 1978-10-10 under 510(k) number K781537. 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 NEBULIZER/HUMIDIFIER?

NEBULIZER/HUMIDIFIER is a medical device that received FDA 510(k) clearance on 1978-10-10. The listed applicant is Chemetron Medical Products, Inc.. The 510(k) number is K781537.

When did NEBULIZER/HUMIDIFIER receive FDA 510(k) clearance?

NEBULIZER/HUMIDIFIER received FDA 510(k) clearance on 1978-10-10, under 510(k) number K781537.

Who is the listed applicant for NEBULIZER/HUMIDIFIER?

The FDA 510(k) record lists Chemetron Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEBULIZER/HUMIDIFIER?

The FDA product code for NEBULIZER/HUMIDIFIER 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.

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Other records listing Chemetron Medical Products, Inc. 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.

K781706RESPIRATOR/GILL 1/SIMVK781542HEATED NEBULIZERK781541FLOMETER

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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