K031948

Substantially Equivalent

PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16

Applicant: Pm Devices, Inc.
Product code: DXZ
Advisory panel: Cardiovascular
Date received: 2003-06-24
Decision date: 2003-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmond, Bc, CA

Adverse events under product code DXZ

product code DXZ

Death: 19
Injury: 265
Total: 284

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.