PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50)

Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea

VENTUS MEDICAL, INC.

The following data is part of a premarket notification filed by Ventus Medical, Inc. with the FDA for Provent Professional Sleep Apnea Therapy (provent 80); Provent Professional Sleep Apnea Therapy (provent 50).

Pre-market Notification Details

• Device ID: K102404
• 510k Number: K102404
• Device Name: PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50)
• Classification: Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea
• Applicant: VENTUS MEDICAL, INC. 1301 SHOREWAY ROAD SUITE 425 Belmont, CA 94002
• Contact: Michael Nevares
• Correspondent: Michael Nevares; VENTUS MEDICAL, INC. 1301 SHOREWAY ROAD SUITE 425 Belmont, CA 94002
• Product Code: OHP
• CFR Regulation Number: 872.5570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-08-24
• Decision Date: 2010-12-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00868020000215	K102404	000
00868020000208	K102404	000