BluePro

Device, Anti-snoring

BlueSom

The following data is part of a premarket notification filed by Bluesom with the FDA for Bluepro.

Pre-market Notification Details

• Device ID: K162192
• 510k Number: K162192
• Device Name: BluePro
• Classification: Device, Anti-snoring
• Applicant: BlueSom 24 Rue Leon Gaumont Orvault, FR 44700
• Contact: Erwan Floch
• Correspondent: Paul Dryden; BlueSom 24 Rue Leon Gaumont Orvault, FR 44700
• Product Code: LRK
• CFR Regulation Number: 872.5570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-08-04
• Decision Date: 2016-12-15
• Summary: summary