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510(k) K072420

MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE by Oceanic Medical Products, Inc. — Product Code BSZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2008
Date Received
August 28, 2007
Clearance Type
Special
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 Oceanic Medical Products, Inc.

  • K060193 — MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 2 (April 10, 2006)
  • K010613 — MAGELLAN-2200, MODEL 1 (October 12, 2001)
  • K002951 — MAGELLAN VENTILATOR (December 8, 2000)

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  • 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)
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