EMBRYOSCOPE

Accessory, Assisted Reproduction

UNISENSE FERTILITECH A/S

The following data is part of a premarket notification filed by Unisense Fertilitech A/s with the FDA for Embryoscope.

Pre-market Notification Details

• Device ID: K111715
• 510k Number: K111715
• Device Name: EMBRYOSCOPE
• Classification: Accessory, Assisted Reproduction
• Applicant: UNISENSE FERTILITECH A/S TUEAGER 1 Arrhus N, DK Dk-8200
• Contact: Mette Munch
• Correspondent: Mette Munch; UNISENSE FERTILITECH A/S TUEAGER 1 Arrhus N, DK Dk-8200
• Product Code: MQG
• CFR Regulation Number: 884.6120 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-06-20
• Decision Date: 2011-08-11
• Summary: summary