510(k) K182311
- Device
- Cervella
- Applicant
- Innovative Neurological Devices LLC
- 510(k) number
- K182311
- Product code
- JXK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-03-07
- Date received
- 2018-08-24
- Regulation
- 882.5800
- Classification name
- Stimulator, Cranial Electrotherapy
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Bart Waclawik
- Address
- 13295 Illinois St., Suite 312 Carmel IN US 46032 46032
FDA Registration Numbers#
- 3007738866
- 3014773746
- 2954783
- 3006258094
- 3027997270
- 2020648
- 8040537
- 3008312728
- 3010900508
- 3014498660
- 3002809311
- 3013526742
- 3005026995