510(k) K230931
K230931 is an FDA 510(k) premarket notification submitted by Drägerwerk AG Co. Kgaa for the device "Atlan". The FDA issued a decision of Substantially Equivalent on July 23, 2023. The device falls under product code BSZ (Gas-Machine, Anesthesia), a Class II device regulated under 21 CFR 868.5160. Drägerwerk AG Co. Kgaa has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 23, 2023
- Date Received
- April 3, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gas-Machine, Anesthesia
- Device Class
- Class II
- Regulation Number
- 868.5160
- Review Panel
- AN
- Submission Type