510(k) K896974— CARDIAC COOLING JACKET, 8 CM, MODEL CJ-120

Substantially Equivalent

Daily Medical Products, Inc.

Clearance details

Applicant: Daily Medical Products, Inc.
Product code: Code DWC
Advisory panel: Cardiovascular
Date received: 1989-12-13
Decision date: 1990-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Adverse events under product code DWC

product code DWC

Death: 124
Injury: 233
Malfunction: 3,727
Total: 4,084

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.