510(k) K971549
K971549 is an FDA 510(k) premarket notification submitted by Target Health, Inc. for the device "VMT SYSTEM". The FDA issued a decision of Substantially Equivalent on October 5, 1998. The device falls under product code LXV (Apparatus, Vestibular Analysis), a Class U device. Target Health, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 5, 1998
- Date Received
- April 28, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Vestibular Analysis
- Device Class
- Class U
- Regulation Number
- Review Panel
- EN
- Submission Type