INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM— 510(k) K080908
Substantially EquivalentInnercool Therapies, Inc.- A Delaware Corporation
FDA 510(k) clearance K080908 for INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM, Substantially Equivalent on 2008-10-17. Applicant: Innercool Therapies, Inc.- A Delaware Corporation.
Clearance details
- Applicant
- Innercool Therapies, Inc.- A Delaware Corporation
- Product code
- Code NCX
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Diego, CA, US
Adverse events under product code NCX
product code NCX- Death
- 30
- Malfunction
- 2,302
- Total
- 2,332
Source: openFDA MAUDE database, through . 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.