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FDA 510(k)

HepaShield Bacterial Viral Breathing System Filter

K-Number: K191909 · 2020-03-23

ApplicantFlexicare Medical Limited.
Decision Date2020-03-23
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HepaShield Bacterial Viral Breathing System Filter is a medical device manufactured by Flexicare Medical Limited.. It received FDA 510(k) clearance on 2020-03-23 under approval number K191909. 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 HepaShield Bacterial Viral Breathing System Filter?

HepaShield Bacterial Viral Breathing System Filter is a medical device that received FDA 510(k) clearance on 2020-03-23. It is manufactured by Flexicare Medical Limited.. The 510(k) number is K191909.

When was HepaShield Bacterial Viral Breathing System Filter approved by the FDA?

HepaShield Bacterial Viral Breathing System Filter received FDA 510(k) clearance on 2020-03-23, under approval number K191909.

What company makes HepaShield Bacterial Viral Breathing System Filter?

HepaShield Bacterial Viral Breathing System Filter is manufactured by Flexicare Medical Limited..

What is the FDA product code for HepaShield Bacterial Viral Breathing System Filter?

The FDA product code for HepaShield Bacterial Viral Breathing System Filter is CAH.

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Related PubMed Literature

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Other Devices by Flexicare Medical Limited.

K161314FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE K160540FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM K163300ThermoShield HME Filter 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 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)

K163300ThermoShield HME FilterFlexicare Medical Limited. K182862Servo GuardMaquet Critical Care AB K190022SafeBreath Filter MouthpieceMD Diagnostics 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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