K231182
- 510(k) number
- K231182
- Device name
- Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System
- Applicant
- Zoll Circulation, Inc. CA · US
- Product code
- NZE — Hyperthermia Monitor
- Decision date
- 2023-11-03
- Date received
- 2023-04-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K231182.pdf
Official FDA record: K231182
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.