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510(k) K133712

EMBRYOVIEWER SOFTWARE by Unisense Fertilitech A/S — Product Code MQG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2014
Date Received
December 5, 2013
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

  • K113075 — EMBRYO VIEWER SOFTWARE (December 21, 2011)
  • K111715 — EMBRYOSCOPE (August 11, 2011)
  • K092183 — EMBRYOSCOPE AND EMBRYOSLIDE (January 11, 2011)

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