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FDA 510(k)

MABIS BRAND AND MABIS CUSTOMERS PRIVATE LABEL BRAND

K-Number: K942072 · 1995-05-10

ApplicantMabis Healthcare, Inc.
Decision Date1995-05-10
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MABIS BRAND AND MABIS CUSTOMERS PRIVATE LABEL BRAND is the device name listed in this FDA 510(k) record. The listed applicant is Mabis Healthcare, Inc.. It received FDA 510(k) clearance on 1995-05-10 under 510(k) number K942072. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MABIS BRAND AND MABIS CUSTOMERS PRIVATE LABEL BRAND?

MABIS BRAND AND MABIS CUSTOMERS PRIVATE LABEL BRAND is a medical device that received FDA 510(k) clearance on 1995-05-10. The listed applicant is Mabis Healthcare, Inc.. The 510(k) number is K942072.

When did MABIS BRAND AND MABIS CUSTOMERS PRIVATE LABEL BRAND receive FDA 510(k) clearance?

MABIS BRAND AND MABIS CUSTOMERS PRIVATE LABEL BRAND received FDA 510(k) clearance on 1995-05-10, under 510(k) number K942072.

Who is the listed applicant for MABIS BRAND AND MABIS CUSTOMERS PRIVATE LABEL BRAND?

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

What is the FDA product code for MABIS BRAND AND MABIS CUSTOMERS PRIVATE LABEL BRAND?

The FDA product code for MABIS BRAND AND MABIS CUSTOMERS PRIVATE LABEL BRAND is DXN.

Related Clinical Trials

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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Other records listing Mabis Healthcare, Inc. 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.

K990506MABIS NB-02 ULTRASONIC NEBULIZER

Related Devices (Code: DXN)

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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