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510(k) K851094

MODEL BION 1/TYPE 1084T CAR IONIZER by Medicor USA , Ltd. — Product Code FRF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1985
Date Received
March 19, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cleaner, Air, Medical Recirculating
Device Class
Class II
Regulation Number
880.5045
Review Panel
HO
Submission Type

Other clearances by Medicor USA , Ltd.

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  • K851358 — MODEL BION 2/TYPE 90 ROOM IONIZER (July 1, 1985)
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  • K840227 — UROLIX-3 UROLOGICAL TABLE (March 23, 1984)
  • K840225 — C-ARM CEILING CRANE FT-2 (March 22, 1984)
  • K840226 — MOTOR TILTED EXAM. TABLE UV-56 (March 16, 1984)
  • K823695 — CPM METABOLIC MONITOR (January 14, 1983)

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