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FDA 510(k)

AQUAPAK PREFILLED HUMIDIFIER

K-Number: K780562 · 1978-04-27

ApplicantRespiratory Care, Inc.
Decision Date1978-04-27
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AQUAPAK PREFILLED HUMIDIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Respiratory Care, Inc.. It received FDA 510(k) clearance on 1978-04-27 under 510(k) number K780562. 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 AQUAPAK PREFILLED HUMIDIFIER?

AQUAPAK PREFILLED HUMIDIFIER is a medical device that received FDA 510(k) clearance on 1978-04-27. The listed applicant is Respiratory Care, Inc.. The 510(k) number is K780562.

When did AQUAPAK PREFILLED HUMIDIFIER receive FDA 510(k) clearance?

AQUAPAK PREFILLED HUMIDIFIER received FDA 510(k) clearance on 1978-04-27, under 510(k) number K780562.

Who is the listed applicant for AQUAPAK PREFILLED HUMIDIFIER?

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

What is the FDA product code for AQUAPAK PREFILLED HUMIDIFIER?

The FDA product code for AQUAPAK PREFILLED HUMIDIFIER is BTT.

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Other records listing Respiratory Care, 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.

K892230RCI VIRAL/BACTERIAL FILTERK884150MODIFIED CONCHATHERM III CONTROLLED HEATERK881625CONCHATHERM III PLUS DUAL HEAT WIRE SERVO CONTROLLK864147AQUAVALVEK863955COLBY LEVEL ALARMK861555CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT

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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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