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510(k) K923433

AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE by Instrumentarium Corp. — Product Code CBQ

K923433 is an FDA 510(k) premarket notification submitted by Instrumentarium Corp. for the device "AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE". The FDA issued a decision of Substantially Equivalent on July 22, 1993. The device falls under product code CBQ (Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)), a Class II device regulated under 21 CFR 868.1500. Instrumentarium Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1993
Date Received
July 13, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
Device Class
Class II
Regulation Number
868.1500
Review Panel
AN
Submission Type

Other clearances by Instrumentarium Corp.

  • K022630 — MODIFICATION TO FOCUS (October 9, 2002)
  • K001729 — FOCUS (July 13, 2000)
  • K001439 — ORTHOCEPH OC100 D (June 22, 2000)
  • K992385 — ORTHOPANTOMOGRAPH OP100D (September 28, 1999)
  • K981641 — MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA (July 17, 1998)
  • K962638 — TONOCAP, TC-200 AND ACCESSORY CATHETERS (April 4, 1997)
  • K961441 — TONOMETERED SLAINE BLOOD GAS CONTROL (April 30, 1996)
  • K955018 — TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR (January 30, 1996)
  • K934478 — ALPHA STEREO (January 31, 1995)
  • K930338 — ORTHOCEPH OC100 (April 27, 1993)

Other clearances for product code CBQ

  • K040917 — PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026B (April 29, 2004)
  • K994188 — MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5 (May 19, 2000)
  • K962648 — OHMEDA MODEL 5330 ANESTHETIC AGENT MONITOR (January 17, 1997)
  • K931439 — OHMEDA MODEL 5330 ANESTHETIC MONITOR (October 19, 1993)
  • K926451 — DATASCOPE MULTINEX II (August 25, 1993)
  • K923276 — CAPNOMAC ULTIMA ANESTHESIA MONITOR (July 21, 1993)
  • K922876 — AS/3 COP MODULE (July 21, 1993)
  • K930303 — DATASCOPE MULTINEX ID PLUS (June 16, 1993)
  • K914295 — ANESTHETIC GAS MONITOR TYPE 1304, MODIFIED (April 10, 1992)
  • K911644 — NGM FRAME (March 4, 1992)

FDA data resources