RAPID-I

Labware, Assisted Reproduction

VITROLIFE SWEDEN AB

The following data is part of a premarket notification filed by Vitrolife Sweden Ab with the FDA for Rapid-i.

Pre-market Notification Details

• Device ID: K090832
• 510k Number: K090832
• Device Name: RAPID-I
• Classification: Labware, Assisted Reproduction
• Applicant: VITROLIFE SWEDEN AB BOX 9080 Se-400 92 Goteborg, SE
• Contact: Kjell Kjork
• Correspondent: Kjell Kjork; VITROLIFE SWEDEN AB BOX 9080 Se-400 92 Goteborg, SE
• Product Code: MQK
• CFR Regulation Number: 884.6160 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-03-26
• Decision Date: 2009-12-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
17350025914395	K090832	000
17350025912247	K090832	000
17350025912230	K090832	000
17350025912223	K090832	000
17350025912216	K090832	000