FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
The IQool System
K Number: K162523
·
Decision May 3, 2017
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
5
Applicant Total
4
Review Days
236
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Basic Information
- Device Name
- The IQool System
- K Number
- K162523
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5900
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Braincool AB
- Date Received
- September 9, 2016
- Decision Date
- May 3, 2017
- Product Code
- NZE
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NZE | Hyperthermia Monitor | FDA class 2 | Cardiovascular |
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