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510(k) K931439

OHMEDA MODEL 5330 ANESTHETIC MONITOR by Ohmeda Medical — Product Code CBQ

K931439 is an FDA 510(k) premarket notification submitted by Ohmeda Medical for the device "OHMEDA MODEL 5330 ANESTHETIC MONITOR". The FDA issued a decision of Substantially Equivalent on October 19, 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. Ohmeda Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1993
Date Received
March 22, 1993
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 Ohmeda Medical

  • K123309 — GIRAFFE AND PANDA WARMERS (February 5, 2013)
  • K101788 — GIRAFFE OMNIBED (July 21, 2010)
  • K101778 — GIRAFFE INCUBATOR (July 21, 2010)
  • K090697 — MODIFICATION TO: GIRAFFE AND PANDA WARMER (April 16, 2009)
  • K072157 — MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POW (August 27, 2007)
  • K070377 — GIRAFFE AND PANDA WARMER (July 11, 2007)
  • K070210 — GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM (April 20, 2007)
  • K070247 — GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM (April 20, 2007)
  • K040068 — BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM (April 16, 2004)
  • K020547 — OHMEDA MEDICAL GIRAFFE INCUBATOR (May 9, 2002)

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)
  • 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