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510(k) K191266

VitalScan ANS by Medeia, Inc. — Product Code JOM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2020
Date Received
May 10, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Device Class
Class II
Regulation Number
870.2780
Review Panel
CV
Submission Type

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  • K172655 — Automated ankle brachial pressure index measuring device (January 11, 2018)
  • K173696 — TBL-ABI System (December 19, 2017)
  • K143152 — TM-ABI system (July 22, 2015)
  • K143094 — QuantaFlo (March 5, 2015)
  • K123921 — BODYTRONIC 200 (April 26, 2013)
  • K121108 — DOPPLEX ABILITY (January 3, 2013)