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510(k) K060193

MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 2 by Oceanic Medical Products, Inc. — Product Code BSZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2006
Date Received
January 25, 2006
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 Oceanic Medical Products, Inc.

  • K072420 — MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE (January 22, 2008)
  • K010613 — MAGELLAN-2200, MODEL 1 (October 12, 2001)
  • K002951 — MAGELLAN VENTILATOR (December 8, 2000)

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