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510(k) K172045

Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2 by Datex-Ohmeda, Inc. — Product Code BSZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 2017
Date Received
July 6, 2017
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 Datex-Ohmeda, Inc.

  • K251663 — Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) (October 22, 2025)
  • K213867 — Carestation 750/750c (March 28, 2023)
  • K210384 — CARESCAPE R860 (November 4, 2021)
  • K172702 — Tec 820, Tec 850 (January 4, 2018)
  • K170872 — Aisys CS2 (August 15, 2017)
  • K151570 — Carestation 620/650/650C (January 21, 2016)
  • K142679 — CARESCAPE R860 (June 12, 2015)
  • K143530 — Aespire View (April 24, 2015)
  • K140575 — ENGSTROM CARESTATION, ENGSTROM PRO (February 3, 2015)
  • K132530 — GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2) (December 20, 2013)

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)
  • K171292 — A7 Anesthesia System (January 12, 2018)
  • K171311 — A5 Anesthesia System (January 12, 2018)
  • K170872 — Aisys CS2 (August 15, 2017)
  • K160665 — FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia Sy (March 29, 2017)
  • K151570 — Carestation 620/650/650C (January 21, 2016)