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510(k) K851358

MODEL BION 2/TYPE 90 ROOM IONIZER by Medicor USA , Ltd. — Product Code FRF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1985
Date Received
April 4, 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

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  • K840226 — MOTOR TILTED EXAM. TABLE UV-56 (March 16, 1984)
  • K823695 — CPM METABOLIC MONITOR (January 14, 1983)

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