Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System
FDA 510(k) clearance K191027 · decided 2020-03-18
Clearance details
- K-number
- K191027
- Device name
- Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System
- Applicant
- Maquet Critical Care AB
- Decision
- Substantially Equivalent
- Date received
- 2019-04-18
- Decision date
- 2020-03-18
- Days to decision
- 335 days
- Clearance type
- Traditional
- Product code
- BSZ
- Device class
- 2
- Regulation number
- 868.5160
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Solna, SE
- Third-party review
- No
- Expedited review
- No
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