CELSIUS CONTROL SYSTEM— 510(k) K033623

Substantially Equivalent

Innercool Therapies, Inc.

FDA 510(k) clearance K033623 for CELSIUS CONTROL SYSTEM, Substantially Equivalent on 2004-05-21. Applicant: Innercool Therapies, Inc..

Clearance details

Applicant: Innercool Therapies, Inc.
Product code: Code NCX
Advisory panel: Cardiovascular
Date received: 2003-11-18
Decision date: 2004-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego,, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NCX

product code NCX

Death: 30
Malfunction: 2,302
Total: 2,332

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.