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FDA 510(k)

VIROTHERM HUMIDIFIER

K-Number: K915603 · 1992-10-22

ApplicantVirotherm Laboratory
Decision Date1992-10-22
Product CodeKFZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VIROTHERM HUMIDIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Virotherm Laboratory. It received FDA 510(k) clearance on 1992-10-22 under 510(k) number K915603. The device is classified under product code KFZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIROTHERM HUMIDIFIER?

VIROTHERM HUMIDIFIER is a medical device that received FDA 510(k) clearance on 1992-10-22. The listed applicant is Virotherm Laboratory. The 510(k) number is K915603.

When did VIROTHERM HUMIDIFIER receive FDA 510(k) clearance?

VIROTHERM HUMIDIFIER received FDA 510(k) clearance on 1992-10-22, under 510(k) number K915603.

Who is the listed applicant for VIROTHERM HUMIDIFIER?

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

What is the FDA product code for VIROTHERM HUMIDIFIER?

The FDA product code for VIROTHERM HUMIDIFIER is KFZ.

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Related Devices (Code: KFZ)

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

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

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