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FDA 510(k)

PRECISION FLOW

K-Number: K072845 · 2008-07-17

ApplicantVapotherm, Inc.
Decision Date2008-07-17
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PRECISION FLOW is the device name listed in this FDA 510(k) record. The listed applicant is Vapotherm, Inc.. It received FDA 510(k) clearance on 2008-07-17 under 510(k) number K072845. 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 PRECISION FLOW?

PRECISION FLOW is a medical device that received FDA 510(k) clearance on 2008-07-17. The listed applicant is Vapotherm, Inc.. The 510(k) number is K072845.

When did PRECISION FLOW receive FDA 510(k) clearance?

PRECISION FLOW received FDA 510(k) clearance on 2008-07-17, under 510(k) number K072845.

Who is the listed applicant for PRECISION FLOW?

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 PRECISION FLOW?

The FDA product code for PRECISION FLOW is BTT.

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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-2K203357HVT 2.0K191010Palladium High Flow Therapy SystemK111640PRECISION FLOW(R) - HELIOX

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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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