EMCOOLSPAD
FDA 510(k) clearance K100071 · decided 2010-10-12
Clearance details
- K-number
- K100071
- Device name
- EMCOOLSPAD
- Applicant
- Emcools Emergency Medical Cooling Systems AG
- Decision
- Substantially Equivalent
- Date received
- 2010-01-11
- Decision date
- 2010-10-12
- Days to decision
- 274 days
- Clearance type
- Traditional
- Product code
- NZE
- Device class
- 2
- Regulation number
- 870.5900
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Vienna, AT
- Third-party review
- Yes
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Emcools Emergency Medical Cooling Systems AG
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad) (K250979) | Zoll Circulation, Inc. | 2025-10-15 |
| CarbonCool® System (K240933) | Global Healthcare SG Sdn. Bhd | 2025-03-18 |
| Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (K231182) | Zoll Circulation, Inc. | 2023-11-03 |
| The IQool System (K162523) | Braincool AB | 2017-05-03 |
| THERMOSUIT SYSTEM (K061023) | Life Recovery Systems Hd, LLC | 2006-09-20 |
Recalls involving this device
No recalls on record reference this clearance.