Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SafeBreath Filter Mouthpiece

K-Number: K190022 · 2019-09-25

ApplicantMD Diagnostics Limited
Decision Date2019-09-25
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SafeBreath Filter Mouthpiece is the device name listed in this FDA 510(k) record. The listed applicant is MD Diagnostics Limited. It received FDA 510(k) clearance on 2019-09-25 under 510(k) 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. The listed applicant is MD Diagnostics Limited. The 510(k) number is K190022.

When did SafeBreath Filter Mouthpiece receive FDA 510(k) clearance?

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

Who is the listed applicant for SafeBreath Filter Mouthpiece?

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

What is the FDA product code for SafeBreath Filter Mouthpiece?

The FDA product code for SafeBreath Filter Mouthpiece is CAH.

Other records listing MD Diagnostics 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.

K171129CO Check Pro, CO Screen

Related Devices (Code: CAH)

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.

K252643Iso-Gard Filter Straight; Humid-Vent Filter Compact AngledTeleflex Medical Sdn. Bhd.K251583Ambu® Virobac II® Exhalation FilterAmbu A/SK241339Besmed Bacterial Filter and HMEFBesmed Health Business CorpK222917Breathing circuit bacterial/viral filterShaoxing Haitech Medical Products Co., Ltd.K230483Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)Passy-Muir, Inc.K223258TNI Clear-Guard™ 3 angled breathing filter (1545020)Intersurgical , 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.

↑