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FDA 510(k)

MODIFIED CONCHATHERM III CONTROLLED HEATER

K-Number: K884150 · 1988-11-21

ApplicantRespiratory Care, Inc.
Decision Date1988-11-21
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODIFIED CONCHATHERM III CONTROLLED HEATER 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 1988-11-21 under 510(k) number K884150. 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 MODIFIED CONCHATHERM III CONTROLLED HEATER?

MODIFIED CONCHATHERM III CONTROLLED HEATER is a medical device that received FDA 510(k) clearance on 1988-11-21. The listed applicant is Respiratory Care, Inc.. The 510(k) number is K884150.

When did MODIFIED CONCHATHERM III CONTROLLED HEATER receive FDA 510(k) clearance?

MODIFIED CONCHATHERM III CONTROLLED HEATER received FDA 510(k) clearance on 1988-11-21, under 510(k) number K884150.

Who is the listed applicant for MODIFIED CONCHATHERM III CONTROLLED HEATER?

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 MODIFIED CONCHATHERM III CONTROLLED HEATER?

The FDA product code for MODIFIED CONCHATHERM III CONTROLLED HEATER 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 FILTERK881625CONCHATHERM III PLUS DUAL HEAT WIRE SERVO CONTROLLK864147AQUAVALVEK863955COLBY LEVEL ALARMK861555CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUITK834151CONCHATHERM LHF HUMIDIFIER HEATER

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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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