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510(k) K252746

Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL) by Drägerwerk AG Co. Kgaa — Product Code BSZ

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

Other clearances by Drägerwerk AG Co. Kgaa

  • K230931 — Atlan (July 23, 2023)

Other clearances for product code BSZ

  • K251352 — Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related (July 11, 2025)
  • K230931 — Atlan (July 23, 2023)
  • K213867 — Carestation 750/750c (March 28, 2023)
  • K201957 — A8, A9 Anesthesia System (March 26, 2021)
  • K191027 — Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System (March 18, 2020)
  • K171311 — A5 Anesthesia System (January 12, 2018)
  • K171292 — A7 Anesthesia System (January 12, 2018)
  • K172045 — Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aesp (November 3, 2017)
  • K170872 — Aisys CS2 (August 15, 2017)
  • K160665 — FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia Sy (March 29, 2017)