DERMAPROOF— 510(k) K914840

Substantially Equivalent

Pharmalett Medical Care, Holland B.V.

FDA 510(k) clearance K914840 for DERMAPROOF, Substantially Equivalent on 1992-01-31. Applicant: Pharmalett Medical Care, Holland B.V..

Clearance details

Applicant: Pharmalett Medical Care, Holland B.V.
Product code: Code FRO
Advisory panel: Unknown
Date received: 1991-10-25
Decision date: 1992-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

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Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

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.