FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
ZANZA-CLICK
K Number: DEN130019
·
Decision Nov 7, 2014
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
1
Applicant Total
5
Review Days
617
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Basic Information
- Device Name
- ZANZA-CLICK
- K Number
- DEN130019
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 882.5894
- Medical Specialty
- Neurology
- Decision
- Unknown
- Applicant
- Tecnimed S.R.L.
- Date Received
- February 28, 2013
- Decision Date
- November 7, 2014
- Product Code
- OSG
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OSG | Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OSG), ordered by most recent decision date.
View allOther Clearances by Tecnimed S.R.L.
| K Number | Device Name | ||
|---|---|---|---|
| K160680 | VisioFocus Mini, VisioFocus Smart | Apr 19, 2017 | Substantially Equivalent |
| K122412 | VISIOFOCUS | Mar 13, 2013 | Substantially Equivalent |
| K072108 | MODIFICATION TO THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES | Aug 31, 2007 | Substantially Equivalent |
| K033790 | THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES | Jun 3, 2004 | Substantially Equivalent |