MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSOR— 510(k) K110956
Substantially EquivalentMedivance, Inc.
FDA 510(k) clearance K110956 for MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSOR, Substantially Equivalent on 2011-07-18. Applicant: Medivance, Inc.. Device class: 2.
Clearance details
- Applicant
- Medivance, Inc.
- Product code
- Code FLL
- Device class
- Class 2
- Regulation
- 21 CFR 880.2910
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Louisville, CO, US
Recent devices under product code FLL
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- K250878 — YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)
More 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 FLL
product code FLL- Death
- 3
- Malfunction
- 557
- Total
- 560
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.