Device type
Gas-Machine, Anesthesia
Product code BSZ · Class II · 21 CFR 868.5160 · Anesthesiology
Recent 510(k)s
No 510(k) clearances in the archive for BSZ.
Recent recalls
Sep 23, 2026
Z-3191-2026
Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
Datex-Ohmeda, Inc.
- BSZ
- Class II
- Ongoing
Sep 23, 2026
Z-3192-2026
Et Control, Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents, Field replaceable unit (FRU) pa…
Datex-Ohmeda, Inc.
- BSZ
- Class II
- Ongoing
Sep 23, 2026
Z-3190-2026
Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000
Datex-Ohmeda, Inc.
- BSZ
- Class II
- Ongoing
Sep 23, 2026
Z-3189-2026
Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000
Datex-Ohmeda, Inc.
- BSZ
- Class II
- Ongoing