AUTOMIX 3+3/AS COMPOUNDER SYSTEM— 510(k) K961008

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K961008 for AUTOMIX 3+3/AS COMPOUNDER SYSTEM, Substantially Equivalent on 1997-10-10. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code LHI
Advisory panel: General Hospital
Date received: 1996-03-12
Decision date: 1997-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Lake, IL, US

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Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

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.