IV-eye
FDA 510(k) clearance K152088 · decided 2016-02-24
Clearance details
- K-number
- K152088
- Device name
- IV-eye
- Applicant
- Novarix Limited
- Decision
- Substantially Equivalent
- Date received
- 2015-07-27
- Decision date
- 2016-02-24
- Days to decision
- 212 days
- Clearance type
- Traditional
- Product code
- KZA
- Device class
- 1
- Regulation number
- 880.6970
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Abingdon, GB
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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| Record | Firm | Date |
|---|---|---|
| VTS1000 (K101838) | Vuetek Scientific, LLC | 2011-02-18 |
| IR VIEWER (K042679) | Infrared Imaging Systems, Inc. | 2004-12-10 |
| ESP7 VENOUS IMAGE (K982612) | Ironmaster, Inc. | 1998-12-14 |
| HYPO-GRIP (K780884) | Harco Products | 1978-08-10 |
| E-Z-JECTOR (K780883) | Harco Products | 1978-08-10 |
Recalls involving this device
No recalls on record reference this clearance.