510(k) DEN200006
- Device
- ClearUP Sinus Relief
- Applicant
- Tivic Health Systems, Inc.
- 510(k) number
- DEN200006
- Product code
- QNU
- Decision
- Unknown (DENG)
- Decision date
- 2021-03-05
- Date received
- 2020-02-07
- Regulation
- 874.6000
- Classification name
- Transcutaneous Electrical Nerve Stimulator For The Relief Of Congestion
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Michael Nketiah
- Address
- 750 Menlo Ave. Suite 200 Menlo Park CA US 94025 94025
FDA Registration Numbers#
- 3015542954
Source Documents#
510(k) summary PDF not indicated by FDA