ESP7 VENOUS IMAGE
FDA 510(k) clearance K982612 · decided 1998-12-14
Clearance details
- K-number
- K982612
- Device name
- ESP7 VENOUS IMAGE
- Applicant
- Ironmaster, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-07-27
- Decision date
- 1998-12-14
- Days to decision
- 140 days
- Clearance type
- Traditional
- Product code
- KZA
- Device class
- 1
- Regulation number
- 880.6970
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Santa Clara, CA, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| IV-eye (K152088) | Novarix Limited | 2016-02-24 |
| VTS1000 (K101838) | Vuetek Scientific, LLC | 2011-02-18 |
| IR VIEWER (K042679) | Infrared Imaging Systems, Inc. | 2004-12-10 |
| 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.