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510(k) K840452

PREMIUM DABM DISPOS. ANES. BREATH MASK by Ohio Medical Products — Product Code BSJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 1984
Date Received
February 1, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Gas, Anesthetic
Device Class
Class I
Regulation Number
868.5550
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)
  • K840858 — OHIO 3300 INFANT WARMER SYSTEM (March 23, 1984)
  • K840967 — OHIO HEAT REFLECTING PATCH (March 23, 1984)
  • K840857 — OHIO 3000 INFANT WARMER SYSTEM (March 23, 1984)
  • K840453 — MEDISHIELD PVM RESPIROMETER (March 2, 1984)
  • K833335 — MODULUS II ANESTHESIA GAS MACHINE (November 14, 1983)
  • K830488 — VENTILATOR #1 (September 15, 1983)

Other clearances for product code BSJ

  • K163277 — SuperNO2VA Device (October 13, 2017)
  • K953107 — ANESTHESIA/RESPIRATORY FACE MASK (August 15, 1995)
  • K953295 — ANESTHESIA FACE MASK (August 11, 1995)
  • K952689 — BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK (July 11, 1995)
  • K951043 — AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK (June 7, 1995)
  • K950771 — DISPOSABLE ADHESIVE FACE MASK (March 10, 1995)
  • K945894 — MASK, GAS, ANESTHETIC (January 27, 1995)
  • K945440 — DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK (November 8, 1994)
  • K944157 — DISPOSABLE, PREFORMED FACE MASK (October 3, 1994)
  • K932147 — NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONE (August 20, 1993)