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510(k) K140264

MADM by Thornhill Research, Inc. — Product Code BSZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2015
Date Received
February 3, 2014
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 Thornhill Research, Inc.

  • DEN170044 — ClearMate (March 14, 2019)
  • K161420 — MOVES SLC (June 6, 2017)
  • K140049 — MOVES SLC (May 29, 2014)
  • K093261 — MOVES (March 26, 2010)

Other clearances for product code BSZ

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  • 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)
  • 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)