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FDA 510(k)

PRECISION FLOW(R) - HELIOX

K-Number: K111640 · 2011-10-07

ApplicantVapotherm, Inc.
Decision Date2011-10-07
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PRECISION FLOW(R) - HELIOX is the device name listed in this FDA 510(k) record. The listed applicant is Vapotherm, Inc.. It received FDA 510(k) clearance on 2011-10-07 under 510(k) number K111640. 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(R) - HELIOX?

PRECISION FLOW(R) - HELIOX is a medical device that received FDA 510(k) clearance on 2011-10-07. The listed applicant is Vapotherm, Inc.. The 510(k) number is K111640.

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

PRECISION FLOW(R) - HELIOX received FDA 510(k) clearance on 2011-10-07, under 510(k) number K111640.

Who is the listed applicant for PRECISION FLOW(R) - HELIOX?

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(R) - HELIOX?

The FDA product code for PRECISION FLOW(R) - HELIOX is BTT.

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Other records listing Vapotherm, Inc. as applicant

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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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