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FDA 510(k)

TAGA VELOCITY PASSOVER HUMIDIFIER WITH HEATER, MODEL TM1000H

K-Number: K040507 · 2004-03-04

ApplicantTaga Medical Technologies, Inc.
Decision Date2004-03-04
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TAGA VELOCITY PASSOVER HUMIDIFIER WITH HEATER, MODEL TM1000H is the device name listed in this FDA 510(k) record. The listed applicant is Taga Medical Technologies, Inc.. It received FDA 510(k) clearance on 2004-03-04 under 510(k) number K040507. 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 TAGA VELOCITY PASSOVER HUMIDIFIER WITH HEATER, MODEL TM1000H?

TAGA VELOCITY PASSOVER HUMIDIFIER WITH HEATER, MODEL TM1000H is a medical device that received FDA 510(k) clearance on 2004-03-04. The listed applicant is Taga Medical Technologies, Inc.. The 510(k) number is K040507.

When did TAGA VELOCITY PASSOVER HUMIDIFIER WITH HEATER, MODEL TM1000H receive FDA 510(k) clearance?

TAGA VELOCITY PASSOVER HUMIDIFIER WITH HEATER, MODEL TM1000H received FDA 510(k) clearance on 2004-03-04, under 510(k) number K040507.

Who is the listed applicant for TAGA VELOCITY PASSOVER HUMIDIFIER WITH HEATER, MODEL TM1000H?

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

What is the FDA product code for TAGA VELOCITY PASSOVER HUMIDIFIER WITH HEATER, MODEL TM1000H?

The FDA product code for TAGA VELOCITY PASSOVER HUMIDIFIER WITH HEATER, MODEL TM1000H is BTT.

Related Clinical Trials

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Other records listing Taga Medical Technologies, 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.

K031179TAGA VELOCITY HUMIDIFIERK010578TAGA VELOCITY PASSOVER HUMIDIFIER UNIT, MODEL MP1017

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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