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FDA 510(k)

TAGA VELOCITY PASSOVER HUMIDIFIER UNIT, MODEL MP1017

K-Number: K010578 · 2001-04-25

ApplicantTaga Medical Technologies, Inc.
Decision Date2001-04-25
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TAGA VELOCITY PASSOVER HUMIDIFIER UNIT, MODEL MP1017 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 2001-04-25 under 510(k) number K010578. 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 UNIT, MODEL MP1017?

TAGA VELOCITY PASSOVER HUMIDIFIER UNIT, MODEL MP1017 is a medical device that received FDA 510(k) clearance on 2001-04-25. The listed applicant is Taga Medical Technologies, Inc.. The 510(k) number is K010578.

When did TAGA VELOCITY PASSOVER HUMIDIFIER UNIT, MODEL MP1017 receive FDA 510(k) clearance?

TAGA VELOCITY PASSOVER HUMIDIFIER UNIT, MODEL MP1017 received FDA 510(k) clearance on 2001-04-25, under 510(k) number K010578.

Who is the listed applicant for TAGA VELOCITY PASSOVER HUMIDIFIER UNIT, MODEL MP1017?

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 UNIT, MODEL MP1017?

The FDA product code for TAGA VELOCITY PASSOVER HUMIDIFIER UNIT, MODEL MP1017 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 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.

K040507TAGA VELOCITY PASSOVER HUMIDIFIER WITH HEATER, MODEL TM1000HK031179TAGA VELOCITY HUMIDIFIER

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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