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510(k) K220907

Device
The iNAP One Sleep Therapy System
Applicant
Somnics, Inc.
510(k) number
K220907
Product code
OZR
Decision
Substantially Equivalent (SESE)
Decision date
2023-06-16
Date received
2022-03-29
Regulation
872.5570
Classification name
Intraoral Pressure Gradient Device
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Chung-Chu Chen
Address
5f, N0. 22, 5f, # 22, Sec. 2, Shengyi Rd., Zhubei City, Hsinchu County TW 30261 30261

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OZR#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K193460The iNAP One Sleep Therapy SystemSomnice, Inc.2020-05-26
K132003WINX SLEEP THERAPY SYSTEMApnicure, Inc.2014-06-13
K130538WINX SLEEP THERAPY SYSTEMApnicure, Inc.2013-05-22
K122130WINX SLEEP THERAPY SYSTEMApnicure, Inc.2012-10-31
K111549ATTUNE SLEEP APNEA SYSTEMApnicure, Inc.2012-03-30