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510(k) DEN120015

EEVA 2.0 by Auxogyn, Inc. — Product Code PBH

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
June 6, 2014
Date Received
August 24, 2012
Clearance Type
Post-NSE
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Embryo Image Assessment System, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6195
Review Panel
OB
Submission Type

The device will obtain and analyze light microscopy images of developing embryos. This device provides information to aid in the selection of embryo(s) for transfer when there are multiple embryos deemed suitable for transfer or freezing .

Other clearances by Auxogyn, Inc.

  • K142147 — EEVA SYSTEM (November 24, 2014)
  • K141663 — EEVA DISH (WITH 12 MICROWELLS) (July 22, 2014)
  • K103028 — EEVATM PETRI DISH (August 11, 2011)

Other clearances for product code PBH

  • K243851 — CHLOE BLAST (August 15, 2025)
  • K182798 — KIDScore D3 (July 19, 2019)
  • K142147 — EEVA SYSTEM (November 24, 2014)