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510(k) K810660

KREMER CORNEOMETER ULTRASONIC PACHOMETER by Accutome, Inc. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1981
Date Received
March 11, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

Other clearances by Accutome, Inc.

  • K152573 — 4Sight (November 25, 2015)
  • K132549 — ACCUTIP COVER (April 23, 2014)
  • K123349 — A-SCAN PLUS CONNECT (January 29, 2013)
  • K103471 — UBM PLUS (March 14, 2011)
  • K050552 — PACHPEN PACHYMETER, MODEL 24-5100 (March 28, 2005)
  • K032956 — ACCUSONIC A-SCAN MODEL, 24-4000 (October 10, 2003)
  • K820050 — KREMER BLADE GAUGE (February 24, 1982)

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  • K250381 — Deepsight NeedleVue LC1 Ultrasound System (August 1, 2025)
  • K243227 — B-Scan (July 11, 2025)
  • K251728 — Velacur One (LI-1100) (June 26, 2025)
  • K243880 — Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini (June 17, 2025)
  • K243937 — Accuro 3S (May 23, 2025)
  • K243479 — EchoGuide (Version 1) (April 23, 2025)