FLO-GARD 2100 - 2M8281M— 510(k) K923066

Name: FDA 510(k) clearance K923066
Creator: U.S. Food and Drug Administration
Published: 1993-05-13

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K923066 for FLO-GARD 2100 - 2M8281M, Substantially Equivalent on 1993-05-13. Applicant: Baxter Healthcare Corp. Device class: 2.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code LZH
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 1992-06-25
Decision date: 1993-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Lake, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LZH

product code LZH

Death: 12
Malfunction: 4,186
Total: 4,198

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.