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FDA 510(k)

AMERICAN BANTEX, MODEL MS 3

K-Number: K042104 · 2004-10-21

ApplicantAmerican Bantex Corp.
Decision Date2004-10-21
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

AMERICAN BANTEX, MODEL MS 3 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 2004-10-21 under 510(k) number K042104. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERICAN BANTEX, MODEL MS 3?

AMERICAN BANTEX, MODEL MS 3 is a medical device that received FDA 510(k) clearance on 2004-10-21. The listed applicant is American Bantex Corp.. The 510(k) number is K042104.

When did AMERICAN BANTEX, MODEL MS 3 receive FDA 510(k) clearance?

AMERICAN BANTEX, MODEL MS 3 received FDA 510(k) clearance on 2004-10-21, under 510(k) number K042104.

Who is the listed applicant for AMERICAN BANTEX, MODEL MS 3?

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, MODEL MS 3?

The FDA product code for AMERICAN BANTEX, MODEL MS 3 is INI.

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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.

K041963AMERICAN BANTEX HUMIDIFIER, DRY, BUBBLE, MODELS B9000, 3 PSI AND B9100, 6 PSIK040754AMERICAN BANTEX MS 4 MINI SCOOTERK031711TANGO, MODELS, BP1K963218BANTEX SURGICAL LATEX GLOVES- TYPE 1 NATURAL RUBBER LATEX SURGICSL GLOVES, STERILE

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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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