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510(k) K933285

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

K933285 is an FDA 510(k) premarket notification submitted by Datex Division Instrumentarium Corp. for the device "DATEX AS/3 TM ANAESTHESIA MONITOR". The FDA issued a decision of Substantially Equivalent on November 14, 1994. The device falls under product code BSZ (Gas-Machine, Anesthesia), a Class II device regulated under 21 CFR 868.5160. Datex Division Instrumentarium Corp. has at least 10 other 510(k) clearances on record.

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)

Other clearances for product code BSZ

  • K253330 — A5 Anesthesia System (A5); A7 Anesthesia System (A7) (June 25, 2026)
  • K252746 — Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL) (May 21, 2026)
  • K251352 — Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related (July 11, 2025)
  • K230931 — Atlan (July 23, 2023)
  • K213867 — Carestation 750/750c (March 28, 2023)
  • K201957 — A8, A9 Anesthesia System (March 26, 2021)
  • K191027 — Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System (March 18, 2020)
  • K171292 — A7 Anesthesia System (January 12, 2018)
  • K171311 — A5 Anesthesia System (January 12, 2018)
  • K172045 — Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aesp (November 3, 2017)

FDA data resources