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510(k) K193460

Device
The INAP One Sleep Therapy System
Applicant
Somnice, Inc.
510(k) number
K193460
Product code
OZR  
Decision
Substantially Equivalent (SESE)
Decision date
2020-05-26
Date received
2019-12-16
Regulation
872.5570
Classification name
Intraoral Pressure Gradient Device
Medical specialty
Dental
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Sujith Shetty
Address
5f, # 22, Sec. 2, Shengyi Rd., Hsinchu Science Park, 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
K220907The iNAP One Sleep Therapy SystemSomnics, Inc.2023-06-16
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

Legacy Summary#

summary

FDA Review#

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