510(k) K252746
K252746 is an FDA 510(k) premarket notification submitted by Drägerwerk AG Co. Kgaa for the device "Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)". The FDA issued a decision of Substantially Equivalent on May 21, 2026. 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
- May 21, 2026
- Date Received
- August 29, 2025
- 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