Arctic Sun Stat Temperature Management System— 510(k) K200225
Substantially EquivalentMedivance, Inc.
FDA 510(k) clearance K200225 for Arctic Sun Stat Temperature Management System, Substantially Equivalent on 2020-02-28. Applicant: Medivance, Inc.. Device class: 2.
Clearance details
- Applicant
- Medivance, Inc.
- Product code
- Code DWJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.5900
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Louisville, CO, US
Recent devices under product code DWJ
view allMore clearances from Medivance, Inc.
view all- K251974 — Arctic Sun Temperature Management System (Model 5000)
- K243942 — Arctic Sun Stat Temperature Management System
- K161602 — Arctic Sun Temperature Management System
- K142702 — Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad
- K120849 — HYBRID ARCTICGEL PAD
Adverse events under product code DWJ
product code DWJ- Death
- 7
- Injury
- 679
- Malfunction
- 17,477
- Total
- 18,163
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K200225
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K200225.
Data sourced from openFDA. This site is unofficial and independent of the FDA.