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510(k) K823922

COMPUTERIZED SPIROMETRY SYSTEM by Ohio Medical Products — Product Code BZK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1983
Date Received
December 28, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Monitoring (W/Wo Alarm)
Device Class
Class II
Regulation Number
868.1850
Review Panel
AN
Submission Type

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  • K841274 — BAG-TO-VENTILATOR SELECTOR VALVE (April 13, 1984)
  • K840857 — OHIO 3000 INFANT WARMER SYSTEM (March 23, 1984)
  • K840967 — OHIO HEAT REFLECTING PATCH (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)

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