Balanceback VNG System
FDA 510(k) K042529 · Fall Prevention Technologies, LLC
510(k) numberK042529
Submission
- Device name
- Balanceback VNG System
- Applicant
- Fall Prevention Technologies, LLC
Boca Raton, FL, US - Received
- September 17, 2004
- Decision date
- October 6, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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More from Dizzydoctor Systems, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K070729 | Balanceback Mobile Intuitive VNG SystemGWN · Traditional | 03/30/2007SE |
Questions and answers
When was Balanceback VNG System cleared by the FDA?
Balanceback VNG System (K042529) received a 510(k) decision of Substantially Equivalent on October 6, 2004, 19 days after the submission was received.
What is the product code of K042529?
The FDA product code is GWN – Nystagmograph, a Class II (moderate risk) device regulated under 21 CFR 882.1460.