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510(k) K083377

ACCUPEN by Accutome Ultrasound, Inc. — Product Code HKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2009
Date Received
November 14, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tonometer, Ac-Powered
Device Class
Class II
Regulation Number
886.1930
Review Panel
OP
Submission Type

Other clearances by Accutome Ultrasound, Inc.

  • K070943 — B-SCAN PLUS (April 19, 2007)
  • K042752 — ACCUPACH V (November 10, 2004)

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