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FDA 510(k)

MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM

K-Number: K912444 · 1992-02-18

ApplicantRadiometer America, Inc.
Decision Date1992-02-18
Product CodeLGM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Radiometer America, Inc.. It received FDA 510(k) clearance on 1992-02-18 under 510(k) number K912444. The device is classified under product code LGM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM?

MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM is a medical device that received FDA 510(k) clearance on 1992-02-18. The listed applicant is Radiometer America, Inc.. The 510(k) number is K912444.

When did MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM receive FDA 510(k) clearance?

MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM received FDA 510(k) clearance on 1992-02-18, under 510(k) number K912444.

Who is the listed applicant for MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM?

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

What is the FDA product code for MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM?

The FDA product code for MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM is LGM.

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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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