510(k) K062284
- Device
- CES ULTRA
- Applicant
- NEURO-FITNESS LLC
- 510(k) number
- K062284
- Product code
- JXK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-04-05
- Date received
- 2006-08-07
- Regulation
- 882.5800
- Classification name
- Cranial Electrotherapy Stimulator To Treat Depression
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEL STEVENS
- Address
- P.O. Box 1031 Snoqualmie WA US 98065 98065
FDA Registration Numbers#
- 3007738866
- 3014773746
- 2954783
- 3006258094
- 3027997270
- 2020648
- 8040537
- 3008312728
- 3010900508
- 3014498660
- 3002809311
- 3013526742
- 3005026995
Source Documents#
Legacy Summary#
summary
FDA Review#
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