SERVO-I VENTILATOR SYSTEM— 510(k) K123149
Substantially EquivalentMaquet Critical Care AB
FDA 510(k) clearance K123149 for SERVO-I VENTILATOR SYSTEM, Substantially Equivalent on 2014-06-20. Applicant: Maquet Critical Care AB. Device class: 2.
Clearance details
- Applicant
- Maquet Critical Care AB
- Product code
- Code CBK
- Device class
- Class 2
- Regulation
- 21 CFR 868.5895
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Wayne, NJ, US
Recent devices under product code CBK
view allMore clearances from Maquet Critical Care AB
view all- K253715 — Edi Catheter ENFit 6Fr/48 cm (6893166) +7 more
- K230173 — Servo-air Lite Ventilator System
- K201874 — Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1
- K191027 — Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System
- K182862 — Servo Guard
Adverse events under product code CBK
product code CBK- Death
- 736
- Injury
- 3,628
- Malfunction
- 98,786
- Other
- 4
- Total
- 103,154
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 K123149
K-number listed on FDA's recall record- Z-0092-2021 — Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended for general and critical ventilator care, and it can be used for low end to high end intensive care, in different configurations. It supports a variety of breathing modes and can be used for Neonates, Pediatric and Adults.
- Z-1224-2015 — Servo-I ventilator system CO2 analyzer. Part number 65 23 588.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123149.
Data sourced from openFDA. This site is unofficial and independent of the FDA.