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FDA 510(k)

VENTLAB 6000 SERIES HUMIDIFIER

K-Number: K093617 · 2011-01-27

ApplicantVentlab Corp.
Decision Date2011-01-27
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VENTLAB 6000 SERIES HUMIDIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Ventlab Corp.. It received FDA 510(k) clearance on 2011-01-27 under 510(k) number K093617. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENTLAB 6000 SERIES HUMIDIFIER?

VENTLAB 6000 SERIES HUMIDIFIER is a medical device that received FDA 510(k) clearance on 2011-01-27. The listed applicant is Ventlab Corp.. The 510(k) number is K093617.

When did VENTLAB 6000 SERIES HUMIDIFIER receive FDA 510(k) clearance?

VENTLAB 6000 SERIES HUMIDIFIER received FDA 510(k) clearance on 2011-01-27, under 510(k) number K093617.

Who is the listed applicant for VENTLAB 6000 SERIES HUMIDIFIER?

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

What is the FDA product code for VENTLAB 6000 SERIES HUMIDIFIER?

The FDA product code for VENTLAB 6000 SERIES HUMIDIFIER is BTT.

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Other records listing Ventlab Corp. as applicant

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Related Devices (Code: BTT)

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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