myVision Track Model 005
FDA 510(k) K143211 · Vital Art and Science Incorporated
510(k) numberK143211
Submission
- Device name
- myVision Track Model 005
- Applicant
- Vital Art and Science Incorporated
Richardson, TX, US - Received
- November 10, 2014
- Decision date
- March 20, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HOQ – Grid, Amsler
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1330
- Specialty
- Ophthalmic
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| 510(k) | Device | Decision |
|---|---|---|
| K121738 | Myvisiontrack(Tm)HOQ · Traditional | 02/22/2013SE |
Questions and answers
When was myVision Track Model 005 cleared by the FDA?
myVision Track Model 005 (K143211) received a 510(k) decision of Substantially Equivalent on March 20, 2015, 130 days after the submission was received.
What is the product code of K143211?
The FDA product code is HOQ – Grid, Amsler, a Class I (low risk) device regulated under 21 CFR 886.1330.