GE DATEX-OHMEDA AVANCE— 510(k) K112722
Substantially EquivalentDatex-Ohmeda, Inc.
FDA 510(k) clearance K112722 for GE DATEX-OHMEDA AVANCE, Substantially Equivalent on 2011-12-16. Applicant: Datex-Ohmeda, Inc.. Device class: 2.
Clearance details
- Applicant
- Datex-Ohmeda, Inc.
- Product code
- Code BSZ
- Device class
- Class 2
- Regulation
- 21 CFR 868.5160
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Madison, WI, US
Recent devices under product code BSZ
view allMore clearances from Datex-Ohmeda, Inc.
view allAdverse events under product code BSZ
product code BSZ- Death
- 23
- Injury
- 298
- Malfunction
- 32,987
- Total
- 33,308
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 K112722
K-number listed on FDA's recall record- Z-0755-2017 — GE Healthcare, Avance, Avance CS2, Amingo.
- Z-0681-2016 — GE Healthcare, Aisys CS2,1011-9050-000; Avance Amingo,1009-9002-000, & Avance CS2, 1009-9050-000. The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.
- Z-0009-2014 — GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation.
- Z-0010-2014 — GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for volume or pressure control ventilation.
- Z-1443-2013 — Canister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or M1084850. Intended to provide general inhalation anesthesia and ventilatory support.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112722.
Data sourced from openFDA. This site is unofficial and independent of the FDA.