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510(k) K053420

TENACORE SP02 SENSORS by Tenacore Holdings, Inc. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2006
Date Received
December 8, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type

Other clearances by Tenacore Holdings, Inc.

  • K081335 — TENACORE OXYGEN BLENDER, MODEL TB-2000 (November 14, 2008)
  • K043075 — TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING (August 18, 2005)
  • K012041 — THE HAMMER MODEL H100 (March 28, 2002)

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