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FDA 510(k)

KMA-1300F

K-Number: K841370 · 1984-06-07

ApplicantMedimex, Inc.
Decision Date1984-06-07
Product CodeBSZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

KMA-1300F is the device name listed in this FDA 510(k) record. The listed applicant is Medimex, Inc.. It received FDA 510(k) clearance on 1984-06-07 under 510(k) number K841370. The device is classified under product code BSZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KMA-1300F?

KMA-1300F is a medical device that received FDA 510(k) clearance on 1984-06-07. The listed applicant is Medimex, Inc.. The 510(k) number is K841370.

When did KMA-1300F receive FDA 510(k) clearance?

KMA-1300F received FDA 510(k) clearance on 1984-06-07, under 510(k) number K841370.

Who is the listed applicant for KMA-1300F?

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

What is the FDA product code for KMA-1300F?

The FDA product code for KMA-1300F is BSZ.

Other records listing Medimex, 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.

K871009MVP-1500 CONTINUOUS VENTILATORK860798ARF-1500 CONTINUOUS VENTILATOR

Related Devices (Code: BSZ)

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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