EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400— 510(k) K002705

Substantially Equivalent

Baxa Corp.

FDA 510(k) clearance K002705 for EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400, Substantially Equivalent on 2001-03-28. Applicant: Baxa Corp..

Clearance details

Applicant: Baxa Corp.
Product code: Code LHI
Advisory panel: General Hospital
Date received: 2000-08-30
Decision date: 2001-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, 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.