VMT System
FDA 510(k) K971549 · Target Health, Inc.
510(k) numberK971549
Submission
- Device name
- VMT System
- Applicant
- Target Health, Inc.
New York, NY, US - Received
- April 28, 1997
- Decision date
- October 5, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LXV – Apparatus, Vestibular Analysis
- Device class
- Unclassified
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| K121590 | Vestibular Analysis ApparatusLXV · Traditional | Capacity Sports, LLC | 09/20/2012SE |
| K102364 | Nydiag 200LXV · Traditional | Interacoustics A/S | 12/23/2010SE |
| K082634 | Vertigone BPPV GoggleLXV · Traditional | Vertigone, Inc. | 04/07/2009SE |
| K081602 | DizzyfixLXV · Traditional | Clearwater Clinical Limited | 09/19/2008SE |
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Questions and answers
When was VMT System cleared by the FDA?
VMT System (K971549) received a 510(k) decision of Substantially Equivalent on October 5, 1998, 525 days after the submission was received.
What is the product code of K971549?
The FDA product code is LXV – Apparatus, Vestibular Analysis, a Unclassified device.