CIPA (ADULTS) CIPI (INFANTS)— 510(k) K992932

Substantially Equivalent

Dmc Medical, Ltd.

FDA 510(k) clearance K992932 for CIPA (ADULTS) CIPI (INFANTS), Substantially Equivalent on 2000-06-07. Applicant: Dmc Medical, Ltd..

Clearance details

Applicant: Dmc Medical, Ltd.
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 1999-08-31
Decision date: 2000-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fullerton, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DWF

product code DWF

Death: 106
Injury: 386
Malfunction: 2,323
Total: 2,815

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.