510(k) DEN130019
- Device
- ZANZA-CLICK
- Applicant
- Tecnimed S.R.L.
- 510(k) number
- DEN130019
- Product code
- OSG
- Decision
- Unknown (DENG)
- Decision date
- 2014-11-07
- Date received
- 2013-02-28
- Regulation
- 882.5894
- Classification name
- Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Claude Berthoin
- Address
- 110 E. Granada Blvd. Suite 209 Ormond Beach FL US 32176 32176
FDA Registration Numbers#
- 3003741676
- 3030541658
- 3012341715
- 3017858989
- 3008573045
- 9615140
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code OSG#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN100024 | ZAP-IT! | Ecobrands , Ltd. | 2014-11-07 |