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FDA 510(k)

AMERICAN BANTEX HUMIDIFIER, DRY, BUBBLE, MODELS B9000, 3 PSI AND B9100, 6 PSI

K-Number: K041963 · 2004-10-20

ApplicantAmerican Bantex Corp.
Decision Date2004-10-20
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AMERICAN BANTEX HUMIDIFIER, DRY, BUBBLE, MODELS B9000, 3 PSI AND B9100, 6 PSI is the device name listed in this FDA 510(k) record. The listed applicant is American Bantex Corp.. It received FDA 510(k) clearance on 2004-10-20 under 510(k) number K041963. 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 AMERICAN BANTEX HUMIDIFIER, DRY, BUBBLE, MODELS B9000, 3 PSI AND B9100, 6 PSI?

AMERICAN BANTEX HUMIDIFIER, DRY, BUBBLE, MODELS B9000, 3 PSI AND B9100, 6 PSI is a medical device that received FDA 510(k) clearance on 2004-10-20. The listed applicant is American Bantex Corp.. The 510(k) number is K041963.

When did AMERICAN BANTEX HUMIDIFIER, DRY, BUBBLE, MODELS B9000, 3 PSI AND B9100, 6 PSI receive FDA 510(k) clearance?

AMERICAN BANTEX HUMIDIFIER, DRY, BUBBLE, MODELS B9000, 3 PSI AND B9100, 6 PSI received FDA 510(k) clearance on 2004-10-20, under 510(k) number K041963.

Who is the listed applicant for AMERICAN BANTEX HUMIDIFIER, DRY, BUBBLE, MODELS B9000, 3 PSI AND B9100, 6 PSI?

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

What is the FDA product code for AMERICAN BANTEX HUMIDIFIER, DRY, BUBBLE, MODELS B9000, 3 PSI AND B9100, 6 PSI?

The FDA product code for AMERICAN BANTEX HUMIDIFIER, DRY, BUBBLE, MODELS B9000, 3 PSI AND B9100, 6 PSI is BTT.

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Other records listing American Bantex Corp. 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.

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Related Devices (Code: BTT)

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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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