K250979
- 510(k) number
- K250979
- Device name
- Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad)
- Applicant
- Zoll Circulation, Inc. CA · US
- Product code
- NZE — Hyperthermia Monitor
- Decision date
- 2025-10-15
- Date received
- 2025-03-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K250979.pdf
Official FDA record: K250979
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.