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510(k) K933285

DATEX AS/3 TM ANAESTHESIA MONITOR by Datex Division Instrumentarium Corp. — Product Code BSZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 1994
Date Received
July 6, 1993
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 Datex Division Instrumentarium Corp.

  • K953175 — AS/3 ESTPR MODULE (February 6, 1997)
  • K961247 — AS/3 LIGHT MONITOR (October 23, 1996)
  • K943458 — AS/3 AIRWAY MODULE (February 14, 1995)
  • K945234 — AS/3 MEMORY MODULE, M0MEM (January 27, 1995)
  • K933156 — DATEX AS/3 PATIENT MONITOR (December 30, 1994)
  • K943456 — AS/3 NELLCOR COMPATIBLE SATURATION MOODULE, M-NSAT (October 17, 1994)
  • K923172 — ANAESTHESIA RECORD KEEPER (August 9, 1994)
  • K935477 — AS/3(TM) ANESTHESIA MONITOR SYST INTERFACE BOARD (August 1, 1994)
  • K943457 — AS/3 PRESSURE TEMPERATURE MODULE, M-PT (July 27, 1994)
  • K933284 — AS/3 TM NETWORK (July 11, 1994)

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