ZAP-IT!
FDA 510(k) clearance DEN100024 · decided 2014-11-07
Clearance details
- K-number
- DEN100024
- Device name
- ZAP-IT!
- Applicant
- Ecobrands , Ltd.
- Decision
- Unknown
- Date received
- 2010-09-09
- Decision date
- 2014-11-07
- Days to decision
- 1520 days
- Clearance type
- Post-NSE
- Product code
- OSG
- Device class
- 2
- Regulation number
- 882.5894
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Greenwood Village, CO, 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 |
|---|---|---|
| ZANZA-CLICK (DEN130019) | Tecnimed S.R.L. | 2014-11-07 |
Recalls involving this device
No recalls on record reference this clearance.