FDA 510(k)

AUTOMIX PLUS, 3+3, MICROMIX COMPOUNDING SYSTEM;

K-Number: K955622 · 1997-05-06

Decision Date1997-05-06

Product CodeLHI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

AUTOMIX PLUS, 3+3, MICROMIX COMPOUNDING SYSTEM; is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1997-05-06 under 510(k) number K955622. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOMIX PLUS, 3+3, MICROMIX COMPOUNDING SYSTEM;?

AUTOMIX PLUS, 3+3, MICROMIX COMPOUNDING SYSTEM; is a medical device that received FDA 510(k) clearance on 1997-05-06. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K955622.

When did AUTOMIX PLUS, 3+3, MICROMIX COMPOUNDING SYSTEM; receive FDA 510(k) clearance?

AUTOMIX PLUS, 3+3, MICROMIX COMPOUNDING SYSTEM; received FDA 510(k) clearance on 1997-05-06, under 510(k) number K955622.

Who is the listed applicant for AUTOMIX PLUS, 3+3, MICROMIX COMPOUNDING SYSTEM;?

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

What is the FDA product code for AUTOMIX PLUS, 3+3, MICROMIX COMPOUNDING SYSTEM;?

The FDA product code for AUTOMIX PLUS, 3+3, MICROMIX COMPOUNDING SYSTEM; is LHI.

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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.