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FDA 510(k)

ThermoShield HME Filter

K-Number: K163300 · 2017-03-22

ApplicantFlexicare Medical Limited.
Decision Date2017-03-22
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ThermoShield HME Filter is a medical device manufactured by Flexicare Medical Limited.. It received FDA 510(k) clearance on 2017-03-22 under approval number K163300. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ThermoShield HME Filter?

ThermoShield HME Filter is a medical device that received FDA 510(k) clearance on 2017-03-22. It is manufactured by Flexicare Medical Limited.. The 510(k) number is K163300.

When was ThermoShield HME Filter approved by the FDA?

ThermoShield HME Filter received FDA 510(k) clearance on 2017-03-22, under approval number K163300.

What company makes ThermoShield HME Filter?

ThermoShield HME Filter is manufactured by Flexicare Medical Limited..

What is the FDA product code for ThermoShield HME Filter?

The FDA product code for ThermoShield HME Filter is CAH.

Other Devices by Flexicare Medical Limited.

K161314FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE K160540FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM K181583Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20 K201666SINGLE USE MANOMETER K191909HepaShield Bacterial Viral Breathing System Filter K250243ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U)

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Related Devices (Code: CAH)

K182862Servo GuardMaquet Critical Care AB K190022SafeBreath Filter MouthpieceMD Diagnostics Limited K191909HepaShield Bacterial Viral Breathing System FilterFlexicare Medical Limited. K192713Altera Filter and HME/FilterMeditera Tibbi Malzeme San VE Tic AS K211286Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture ExchangerPall Corporation K202459Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/FilterPharma System AB

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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