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FDA 510(k)

HVT 2.0

K-Number: K203357 · 2021-08-25

ApplicantVapotherm, Inc.
Decision Date2021-08-25
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HVT 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Vapotherm, Inc.. It received FDA 510(k) clearance on 2021-08-25 under 510(k) number K203357. 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 HVT 2.0?

HVT 2.0 is a medical device that received FDA 510(k) clearance on 2021-08-25. The listed applicant is Vapotherm, Inc.. The 510(k) number is K203357.

When did HVT 2.0 receive FDA 510(k) clearance?

HVT 2.0 received FDA 510(k) clearance on 2021-08-25, under 510(k) number K203357.

Who is the listed applicant for HVT 2.0?

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

What is the FDA product code for HVT 2.0?

The FDA product code for HVT 2.0 is BTT.

Other records listing Vapotherm, 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.

K254078HVT 2.0K221318HVT 2.0K220869Vapotherm Aerosol Adapter AAA-2K191010Palladium High Flow Therapy System

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.

K254078HVT 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, LPK251611Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE)Fisher & Paykel Healthcare, Ltd.

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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