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FDA 510(k), K102404, PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50)
FDA 510(k), K102404, PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50)
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510(K) Number: K102404
Device Name: PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50)
Manufacturer: VENTUS MEDICAL, INC.
Device Classification Name: expiratory resistance valve, intranasal, for obstructive sleep apnea
Regulation Number: 872.5570
Classification Product Code: OHP
Date Received: 08/24/2010
Decision Date: 12/02/2010
Regulation Medical Specialty: Dental
Device Name: PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50)
Manufacturer: VENTUS MEDICAL, INC.
Device Classification Name: expiratory resistance valve, intranasal, for obstructive sleep apnea
Regulation Number: 872.5570
Classification Product Code: OHP
Date Received: 08/24/2010
Decision Date: 12/02/2010
Regulation Medical Specialty: Dental
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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