APNEARX

Device, Anti-snoring

APNEA SCIENCE CORPORATION

The following data is part of a premarket notification filed by Apnea Science Corporation with the FDA for Apnearx.

Pre-market Notification Details

• Device ID: K113569
• 510k Number: K113569
• Device Name: APNEARX
• Classification: Device, Anti-snoring
• Applicant: APNEA SCIENCE CORPORATION 49 COASTAL OAK Aliso Viejo, CA 92656
• Contact: Gary Mocnik
• Correspondent: Gary Mocnik; APNEA SCIENCE CORPORATION 49 COASTAL OAK Aliso Viejo, CA 92656
• Product Code: LRK
• CFR Regulation Number: 872.5570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-12-02
• Decision Date: 2012-03-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00861481000381	K113569	000
00861481000329	K113569	000