510(k) DEN130019
DEN130019 is an FDA 510(k) premarket notification submitted by Tecnimed S.R.L. for the device "ZANZA-CLICK". The FDA issued a decision of De Novo granted on Nov 7, 2014. The device falls under product code OSG (Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch), a Class II device regulated under 21 CFR 882.5894. Tecnimed S.R.L. has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo granted)
- Decision Date
- Nov 7, 2014
- Date Received
- Feb 28, 2013
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch
- Device Class
- Class II
- Regulation Number
- 882.5894
- Review Panel
- NE
- Submission Type
- 510(k) Exempt
Relief / Reduction of Mosquito Bite Itch