Servo Guard— 510(k) K182862
Substantially EquivalentMaquet Critical Care AB
FDA 510(k) clearance K182862 for Servo Guard, Substantially Equivalent on 2019-10-21. Applicant: Maquet Critical Care AB. Device class: 2.
Clearance details
- Applicant
- Maquet Critical Care AB
- Product code
- Code CAH
- Device class
- Class 2
- Regulation
- 21 CFR 868.5260
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Solna, SE
Recent devices under product code CAH
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
- K180098 — SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1
Adverse events under product code CAH
product code CAH- Death
- 7
- Total
- 7
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.