Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad)— 510(k) K250979
Substantially EquivalentZoll Circulation, Inc.
FDA 510(k) clearance K250979 for Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad), Substantially Equivalent on 2025-10-15. Applicant: Zoll Circulation, Inc.. Device class: 2.
Clearance details
- Applicant
- Zoll Circulation, Inc.
- Product code
- Code NZE
- Device class
- Class 2
- Regulation
- 21 CFR 870.5900
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
Recent devices under product code NZE
view allMore clearances from Zoll Circulation, Inc.
view all- K221700 — AutoPulse NXT Resuscitation System
- K223746 — Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console
- K220008 — Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console
- K213031 — Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console
- K153226 — Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit
Data sourced from openFDA. This site is unofficial and independent of the FDA.