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510(k) K833452

OHIO GMS ABSORBER by Airco/Ohio Medical Products — Product Code BSF

K833452 is an FDA 510(k) premarket notification submitted by Airco/Ohio Medical Products for the device "OHIO GMS ABSORBER". The FDA issued a decision of Substantially Equivalent on November 29, 1983. The device falls under product code BSF (Absorber, Carbon-Dioxide), a Class I device regulated under 21 CFR 868.5310. Airco/Ohio Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1983
Date Received
September 23, 1983
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 Airco/Ohio Medical Products

  • K833459 — COAXIAL VOL. VENTILATOR CIRCUIT (January 10, 1984)
  • K832418 — OHIO TEMPERATURE SIMULATOR (September 12, 1983)
  • K832565 — OHIO 5400 VOLUME MONITOR (September 1, 1983)
  • K832185 — OHIO MODEL 922 SPIROMETER (August 12, 1983)
  • K830446 — OXYGEN MONITOR OHIO 5100 (March 24, 1983)
  • K822456 — OHIO V5A ANESTHESIA VENTILATOR (September 21, 1982)
  • K813476 — OHIO VOLUME INCENTIVE SPIROMETER (December 31, 1981)
  • K812880 — OHIO NON-REUSABLE TRACHEAL TUBE MAJILL (November 24, 1981)
  • K812879 — OHIO NON-REUSABLE TRACHEAL TUBE MURPHY (November 24, 1981)
  • K811413 — DABC NONCONDUCTIVE PEDIAT. ANESTH. CIR (June 2, 1981)

Other clearances for product code BSF

  • K951093 — KAB SYSTEM (March 24, 1995)
  • K852071 — OHMEDA GMS ABOSORBER (July 15, 1985)
  • K843422 — OHMEDA BAIN CIRCUIT ADAPTER GMS ABSOR (October 23, 1984)
  • K834535 — NITROUS OXIDE RECYCLER (June 7, 1984)
  • 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