NightWare Kit, Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple Watch Charging Cable
FDA 510(k) clearance DEN200033 · decided 2020-11-06
Clearance details
- K-number
- DEN200033
- Device name
- NightWare Kit, Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple Watch Charging Cable
- Applicant
- Nightware, Inc.
- Decision
- Unknown
- Date received
- 2020-05-27
- Decision date
- 2020-11-06
- Days to decision
- 163 days
- Clearance type
- Direct
- Product code
- QMZ
- Device class
- 2
- Regulation number
- 882.5705
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Hopkins, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.