MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000— 510(k) K071341
Substantially EquivalentMedivance, Inc.
FDA 510(k) clearance K071341 for MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000, Substantially Equivalent on 2007-08-03. 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
- K200225 — 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
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 K071341
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 K071341.
Data sourced from openFDA. This site is unofficial and independent of the FDA.