PIESOMETER, MODEL MK-1— 510(k) K041169

Substantially Equivalent

Canamet Canadian Natl Medical Technologies, Inc.

FDA 510(k) clearance K041169 for PIESOMETER, MODEL MK-1, Substantially Equivalent on 2004-08-24. Applicant: Canamet Canadian Natl Medical Technologies, Inc..

Clearance details

Applicant: Canamet Canadian Natl Medical Technologies, Inc.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2004-05-04
Decision date: 2004-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deer Field, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

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.