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510(k) K821144

OHIO ABSORBER by Ohio Medical Products — Product Code BSF

K821144 is an FDA 510(k) premarket notification submitted by Ohio Medical Products for the device "OHIO ABSORBER". The FDA issued a decision of Substantially Equivalent on May 28, 1982. The device falls under product code BSF (Absorber, Carbon-Dioxide), a Class I device regulated under 21 CFR 868.5310. Ohio Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1982
Date Received
April 21, 1982
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 Ohio Medical Products

  • K841733 — OHIO WASTE GAS SCAVENGING RESERVOIR (July 11, 1984)
  • K842003 — OHIO WASTE GAS SCAVENGING INTERFACE (May 23, 1984)
  • K840356 — OHIO UNITROL II ANESTHESIA GAS MACHINE (April 20, 1984)
  • K841274 — BAG-TO-VENTILATOR SELECTOR VALVE (April 13, 1984)
  • K840967 — OHIO HEAT REFLECTING PATCH (March 23, 1984)
  • K840857 — OHIO 3000 INFANT WARMER SYSTEM (March 23, 1984)
  • K840858 — OHIO 3300 INFANT WARMER SYSTEM (March 23, 1984)
  • K840453 — MEDISHIELD PVM RESPIROMETER (March 2, 1984)
  • K840452 — PREMIUM DABM DISPOS. ANES. BREATH MASK (February 17, 1984)
  • K833335 — MODULUS II ANESTHESIA GAS MACHINE (November 14, 1983)

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)
  • K833452 — OHIO GMS ABSORBER (November 29, 1983)
  • K801255 — PENLON JUMBO CARBON DIOXIDE ABSORBER (June 4, 1980)
  • K760076 — ABSORBER, ANESTHESIA CIRCLE SYS, CO2 (July 16, 1976)

FDA data resources