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510(k) K040917

PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026B by Philips Medizin Systeme Boeblingen GmbH — Product Code CBQ

K040917 is an FDA 510(k) premarket notification submitted by Philips Medizin Systeme Boeblingen GmbH for the device "PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026B". The FDA issued a decision of Substantially Equivalent on April 29, 2004. The device falls under product code CBQ (Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)), a Class II device regulated under 21 CFR 868.1500. Philips Medizin Systeme Boeblingen GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2004
Date Received
April 8, 2004
Clearance Type
Special
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 Philips Medizin Systeme Boeblingen GmbH

  • K252726 — IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX10 (February 6, 2026)
  • K251146 — IntelliVue Patient monitors MX400, MX450, MX500, MX550 (October 17, 2025)
  • K233440 — Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) (July 2, 2024)
  • K231671 — IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866 (December 19, 2023)
  • K230604 — IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X (November 22, 2023)
  • K223574 — IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866 (August 22, 2023)
  • K210906 — IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4 (October 7, 2021)
  • K212208 — Philips IntelliVue GuardianSoftware (Rev. E.0X) (September 30, 2021)
  • K192137 — IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550 (September 11, 2020)
  • K182979 — IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue (November 19, 2019)

Other clearances for product code CBQ

  • 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)
  • K923433 — AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE (July 22, 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