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510(k) K963415

VENTREX OXYGEN SENSOR by Ventrex, LLC — Product Code CCL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 1996
Date Received
August 30, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Oxygen, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1720
Review Panel
AN
Submission Type

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  • K964821 — COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67 (July 16, 1997)
  • K925044 — VENTREX ALLERGEN DISC (May 14, 1993)
  • K924119 — VENTREX ALLERGEN DISC (November 30, 1992)

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