PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16— 510(k) K031948

Name: FDA 510(k) clearance K031948
Creator: U.S. Food and Drug Administration
Published: 2003-09-16

Substantially Equivalent

Pm Devices, Inc.

FDA 510(k) clearance K031948 for PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16, Substantially Equivalent on 2003-09-16. Applicant: Pm Devices, Inc.. Device class: 2.

Clearance details

Applicant: Pm Devices, Inc.
Product code: Code DXZ
Device class: Class 2
Regulation: 21 CFR 870.3470
Advisory panel: Cardiovascular
Date received: 2003-06-24
Decision date: 2003-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmond, Bc, CA

Download summary PDF View on FDA.gov ↗

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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.