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510(k) K042086

FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM by Draeger Medical, Inc. — Product Code BSZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2004
Date Received
August 3, 2004
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 Draeger Medical, Inc.

  • K121886 — SAVINA 300 SAVINA 300, COUNTRY VARIANTS (August 8, 2014)
  • K133886 — PERSEUS A500 (June 20, 2014)
  • K121999 — GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE (February 28, 2013)
  • 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)
  • K041622 — MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM (July 8, 2004)

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  • K171292 — A7 Anesthesia System (January 12, 2018)
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