510(k) K946229
K946229 is an FDA 510(k) premarket notification submitted by Neurocom International, Inc. for the device "BALANCE MANAGER". The FDA issued a decision of Substantially Equivalent on August 4, 1995. The device falls under product code KHX (Platform, Force-Measuring), a Class I device regulated under 21 CFR 890.1575. Neurocom International, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 4, 1995
- Date Received
- December 22, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Platform, Force-Measuring
- Device Class
- Class I
- Regulation Number
- 890.1575
- Review Panel
- PM
- Submission Type