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510(k) K945234

AS/3 MEMORY MODULE, M0MEM by Datex Division Instrumentarium Corp. — Product Code BSZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1995
Date Received
October 27, 1994
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.

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  • K943458 — AS/3 AIRWAY MODULE (February 14, 1995)
  • K933156 — DATEX AS/3 PATIENT MONITOR (December 30, 1994)
  • K933285 — DATEX AS/3 TM ANAESTHESIA MONITOR (November 14, 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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