ZANZA-CLICK
FDA 510(k) clearance DEN130019 · decided 2014-11-07
Clearance details
- K-number
- DEN130019
- Device name
- ZANZA-CLICK
- Applicant
- Tecnimed S.R.L.
- Decision
- Unknown
- Date received
- 2013-02-28
- Decision date
- 2014-11-07
- Days to decision
- 617 days
- Clearance type
- Direct
- Product code
- OSG
- Device class
- 2
- Regulation number
- 882.5894
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Ormond Beach, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ZAP-IT! (DEN100024) | Ecobrands , Ltd. | 2014-11-07 |
Recalls involving this device
No recalls on record reference this clearance.