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510(k) K843422

OHMEDA BAIN CIRCUIT ADAPTER GMS ABSOR by Ohmeda Medical — Product Code BSF

K843422 is an FDA 510(k) premarket notification submitted by Ohmeda Medical for the device "OHMEDA BAIN CIRCUIT ADAPTER GMS ABSOR". The FDA issued a decision of Substantially Equivalent on October 23, 1984. The device falls under product code BSF (Absorber, Carbon-Dioxide), a Class I device regulated under 21 CFR 868.5310. Ohmeda Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1984
Date Received
August 31, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Absorber, Carbon-Dioxide
Device Class
Class I
Regulation Number
868.5310
Review Panel
AN
Submission Type

Other clearances by Ohmeda Medical

  • K123309 — GIRAFFE AND PANDA WARMERS (February 5, 2013)
  • K101778 — GIRAFFE INCUBATOR (July 21, 2010)
  • K101788 — GIRAFFE OMNIBED (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)
  • K070247 — GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM (April 20, 2007)
  • K070210 — GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM (April 20, 2007)
  • K040068 — BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM (April 16, 2004)
  • K020543 — OHMEDA MEDICAL GIRAFFE OMNIBED (May 9, 2002)

Other clearances for product code BSF

  • K951093 — KAB SYSTEM (March 24, 1995)
  • K852071 — OHMEDA GMS ABOSORBER (July 15, 1985)
  • K834535 — NITROUS OXIDE RECYCLER (June 7, 1984)
  • K833452 — OHIO GMS ABSORBER (November 29, 1983)
  • K821144 — OHIO ABSORBER (May 28, 1982)
  • K801255 — PENLON JUMBO CARBON DIOXIDE ABSORBER (June 4, 1980)
  • K760076 — ABSORBER, ANESTHESIA CIRCLE SYS, CO2 (July 16, 1976)

FDA data resources