FDA 510(k)

SafeBreath Filter Mouthpiece

K-Number: K190022 · 2019-09-25

Decision Date2019-09-25

Product CodeCAH

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

SafeBreath Filter Mouthpiece is a medical device manufactured by MD Diagnostics Limited. It received FDA 510(k) clearance on 2019-09-25 under approval number K190022. 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 SafeBreath Filter Mouthpiece?

SafeBreath Filter Mouthpiece is a medical device that received FDA 510(k) clearance on 2019-09-25. It is manufactured by MD Diagnostics Limited. The 510(k) number is K190022.

When was SafeBreath Filter Mouthpiece approved by the FDA?

SafeBreath Filter Mouthpiece received FDA 510(k) clearance on 2019-09-25, under approval number K190022.

What company makes SafeBreath Filter Mouthpiece?

SafeBreath Filter Mouthpiece is manufactured by MD Diagnostics Limited.

What is the FDA product code for SafeBreath Filter Mouthpiece?

The FDA product code for SafeBreath Filter Mouthpiece is CAH.

Other Devices by MD Diagnostics Limited

K171129CO Check Pro, CO Screen

Related Devices (Code: CAH)

K163300ThermoShield HME FilterFlexicare Medical Limited. K182862Servo GuardMaquet Critical Care AB 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.