FDA 510(k)

PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE)

K-Number: K032716 · 2003-11-28

Decision Date2003-11-28

Product CodeCAH

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE) is the device name listed in this FDA 510(k) record. The listed applicant is Portex , Ltd.. It received FDA 510(k) clearance on 2003-11-28 under 510(k) number K032716. 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 PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE)?

PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE) is a medical device that received FDA 510(k) clearance on 2003-11-28. The listed applicant is Portex , Ltd.. The 510(k) number is K032716.

When did PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE) receive FDA 510(k) clearance?

PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE) received FDA 510(k) clearance on 2003-11-28, under 510(k) number K032716.

Who is the listed applicant for PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE)?

The FDA 510(k) record lists Portex , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE)?

The FDA product code for PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE) is CAH.

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Other records listing Portex , Ltd. as applicant

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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.