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510(k) K092183

EMBRYOSCOPE AND EMBRYOSLIDE by Unisense Fertilitech A/S — Product Code MQG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 2011
Date Received
July 21, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6120
Review Panel
OB
Submission Type

Other clearances by Unisense Fertilitech A/S

  • K133712 — EMBRYOVIEWER SOFTWARE (August 8, 2014)
  • K113075 — EMBRYO VIEWER SOFTWARE (December 21, 2011)
  • K111715 — EMBRYOSCOPE (August 11, 2011)

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  • K180188 — Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish (June 7, 2018)
  • K173264 — EmbryoScope+ (May 11, 2018)
  • K180304 — Geri Embryo Incubator and Geri Dish (April 20, 2018)
  • K171736 — Geri Embryo Incubator and Geri Dish (November 15, 2017)
  • K160753 — COOK Vacuum Pump (June 13, 2017)
  • K160504 — RI Witness Embryology Heated Plate (July 18, 2016)
  • K151357 — MIRI TL (April 22, 2016)
  • K133712 — EMBRYOVIEWER SOFTWARE (August 8, 2014)