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FDA 510(k)

FLO-GARD 2100 - 2M8281M

K-Number: K923066 · 1993-05-13

ApplicantBaxter Healthcare Corp
Decision Date1993-05-13
Product CodeLZH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FLO-GARD 2100 - 2M8281M 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 1993-05-13 under 510(k) number K923066. The device is classified under product code LZH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLO-GARD 2100 - 2M8281M?

FLO-GARD 2100 - 2M8281M is a medical device that received FDA 510(k) clearance on 1993-05-13. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K923066.

When did FLO-GARD 2100 - 2M8281M receive FDA 510(k) clearance?

FLO-GARD 2100 - 2M8281M received FDA 510(k) clearance on 1993-05-13, under 510(k) number K923066.

Who is the listed applicant for FLO-GARD 2100 - 2M8281M?

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 FLO-GARD 2100 - 2M8281M?

The FDA product code for FLO-GARD 2100 - 2M8281M is LZH.

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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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