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FDA 510(k)

FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE

K-Number: K161314 · 2016-07-06

ApplicantFlexicare Medical Limited.
Decision Date2016-07-06
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE is the device name listed in this FDA 510(k) record. The listed applicant is Flexicare Medical Limited.. It received FDA 510(k) clearance on 2016-07-06 under 510(k) number K161314. 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 FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE?

FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE is a medical device that received FDA 510(k) clearance on 2016-07-06. The listed applicant is Flexicare Medical Limited.. The 510(k) number is K161314.

When did FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE receive FDA 510(k) clearance?

FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE received FDA 510(k) clearance on 2016-07-06, under 510(k) number K161314.

Who is the listed applicant for FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE?

The FDA 510(k) record lists Flexicare Medical Limited. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE?

The FDA product code for FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE is BTT.

Other records listing Flexicare Medical Limited. 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.

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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.

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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