PHASEAL— 510(k) K023747

Substantially Equivalent

Carmel Pharma Ab.

FDA 510(k) clearance K023747 for PHASEAL, Substantially Equivalent on 2002-11-15. Applicant: Carmel Pharma Ab..

Clearance details

Applicant: Carmel Pharma Ab.
Product code: Code LHI
Advisory panel: General Hospital
Date received: 2002-11-08
Decision date: 2002-11-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Gothenburg, SE

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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.