AESPIRE 7900, AESPIRE VIEW— 510(k) K122445
Substantially EquivalentDatex-Ohmeda
FDA 510(k) clearance K122445 for AESPIRE 7900, AESPIRE VIEW, Substantially Equivalent on 2012-10-12. Applicant: Datex-Ohmeda. Device class: 2.
Clearance details
- Applicant
- Datex-Ohmeda
- 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
- Special
- Location
- Madison, WI, US
Recent devices under product code BSZ
view allMore clearances from Datex-Ohmeda
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 K122445
K-number listed on FDA's recall record- Z-0677-2016 — GE Healthcare, Aespire 7900, 1009-9012-000 & Aespire View, 1009-9212-000. The family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator (Aespire 7900 and Aespire View) is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The devices are intended for volume or pressure control ventilation.
- Z-1376-2015 — GE Healthcare, Aespire 7900, Aespire View Anesthesia Machines. Model numbers 1009-9012-000. Intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients
- 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 K122445.
Data sourced from openFDA. This site is unofficial and independent of the FDA.