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510(k) K022031

NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2 by Draeger Medical, Inc. — Product Code BSZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2002
Date Received
June 21, 2002
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

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  • K103035 — SMARTPILOT VIEW MODEL MK04500 (March 28, 2012)
  • K082600 — OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 57 (November 26, 2008)
  • K060705 — CARINA HOME (June 14, 2006)
  • K042607 — PRIMUS US (November 26, 2004)
  • K042419 — FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM (October 8, 2004)
  • K042276 — D-VAPOR (September 23, 2004)
  • K042086 — FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM (August 31, 2004)

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