Atlan
FDA 510(k) clearance K230931 · decided 2023-07-23
Clearance details
- K-number
- K230931
- Device name
- Atlan
- Applicant
- Drägerwerk AG Co. Kgaa
- Decision
- Substantially Equivalent
- Date received
- 2023-04-03
- Decision date
- 2023-07-23
- Days to decision
- 111 days
- Clearance type
- Traditional
- Product code
- BSZ
- Device class
- 2
- Regulation number
- 868.5160
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Luebeck, DE
- Third-party review
- No
- Expedited review
- No
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