MOVES— 510(k) K093261
Substantially EquivalentThornhill Research, Inc.
FDA 510(k) clearance K093261 for MOVES, Substantially Equivalent on 2010-03-26. Applicant: Thornhill Research, Inc.. Device class: 2.
Clearance details
- Applicant
- Thornhill Research, Inc.
- Product code
- Code BTL
- Device class
- Class 2
- Regulation
- 21 CFR 868.5925
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Toronto, Ontario, CA
Recent devices under product code BTL
view allMore clearances from Thornhill Research, Inc.
view allAdverse events under product code BTL
product code BTL- Death
- 8
- Malfunction
- 3,256
- Other
- 1
- Total
- 3,265
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 K093261
K-number listed on FDA's recall record- Z-0586-2016 — MOVES System, an emergency ventilator with suction, oxygen concentrator and multi-parameter patient monitoring capabilities. The MOVES System is a portable computer controlled electrically powered transport emergency ventilator intended to provide continuous or intermittent ventilatory support for the care of adults who require ventilation.
- Z-0587-2016 — MOVES System Lithium Polymer Batteries The MOVES System is a portable computer controlled electrically powered transport emergency ventilator intended to provide continuous or intermittent ventilatory support for the care of adults who require ventilation.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093261.
Data sourced from openFDA. This site is unofficial and independent of the FDA.