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510(k) K830488

VENTILATOR #1 by Ohio Medical Products — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1983
Date Received
February 15, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

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  • 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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