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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 the device name listed in this FDA 510(k) record. The listed applicant is Flexicare Medical Limited.. It received FDA 510(k) clearance on 2020-03-23 under 510(k) 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. The listed applicant is Flexicare Medical Limited.. The 510(k) number is K191909.

When did HepaShield Bacterial Viral Breathing System Filter receive FDA 510(k) clearance?

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

Who is the listed applicant for HepaShield Bacterial Viral Breathing System Filter?

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 HepaShield Bacterial Viral Breathing System Filter?

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

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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.

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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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