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510(k) K943521

VIOTEC 1400 SERIES ULTRAVIOLET GERMICIDAL FIXTURE by Schiff & Co. — Product Code FRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 1995
Date Received
July 20, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Purifier, Air, Ultraviolet, Medical
Device Class
Class II
Regulation Number
880.6500
Review Panel
HO
Submission Type

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  • K974141 — PLUS REUSABLE RESUSCITATOR (May 21, 1998)
  • K954448 — VIOTEC V-2200 ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM (October 28, 1996)
  • K955085 — HM-CAP EIA TEST (MODIFICATION) (February 9, 1996)
  • K944159 — HM-CAP EIA KIT (July 18, 1995)
  • K896684 — KEMBLE LIQUID HANDLING SYSTEM DISPENSER (April 16, 1990)
  • K894617 — OLYMPUS PK-TP SYSTEM REACTIVE CONTROL (October 31, 1989)

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