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510(k) K943456

AS/3 NELLCOR COMPATIBLE SATURATION MOODULE, M-NSAT by Datex Division Instrumentarium Corp. — Product Code DQA

K943456 is an FDA 510(k) premarket notification submitted by Datex Division Instrumentarium Corp. for the device "AS/3 NELLCOR COMPATIBLE SATURATION MOODULE, M-NSAT". The FDA issued a decision of Substantially Equivalent on October 17, 1994. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Datex Division Instrumentarium Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1994
Date Received
July 18, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
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)
  • K933285 — DATEX AS/3 TM ANAESTHESIA MONITOR (November 14, 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 DQA

  • K252821 — Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor ( (May 29, 2026)
  • K252655 — Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, P (May 11, 2026)
  • K253887 — Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Na (May 1, 2026)
  • K260931 — Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) (April 14, 2026)
  • K252448 — AViTA Pulse Oximeter (SP61) (February 27, 2026)
  • K252805 — YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) (February 17, 2026)
  • K253109 — Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) (January 7, 2026)
  • K251751 — Spo2 Sensor CSS032D (December 19, 2025)
  • K251691 — Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Senso (December 1, 2025)
  • K251696 — Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusa (December 1, 2025)

FDA data resources