510(k) DEN200033
- Device
- NightWare Kit, Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple Watch Charging Cable
- Applicant
- Nightware, Inc.
- 510(k) number
- DEN200033
- Product code
- QMZ
- Decision
- Unknown (DENG)
- Decision date
- 2020-11-06
- Date received
- 2020-05-27
- Regulation
- 882.5705
- Classification name
- Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Grady Hannah
- Address
- 153 Ashley Rd. Hopkins MN US 55343 55343
FDA Registration Numbers#
- 1424785
- 3017660607
Source Documents#
510(k) summary PDF not indicated by FDA