CARDIAC COOLING JACKED, 16 CM, MODEL CJ-620— 510(k) K896393

Name: FDA 510(k) clearance K896393
Creator: U.S. Food and Drug Administration
Published: 1990-02-02

Substantially Equivalent

Daily Medical, Inc.

FDA 510(k) clearance K896393 for CARDIAC COOLING JACKED, 16 CM, MODEL CJ-620, Substantially Equivalent on 1990-02-02. Applicant: Daily Medical, Inc.. Device class: 2.

Clearance details

Applicant: Daily Medical, Inc.
Product code: Code DWC
Device class: Class 2
Regulation: 21 CFR 870.4250
Advisory panel: Cardiovascular
Date received: 1989-11-06
Decision date: 1990-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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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.