BALANCE MANAGER
FDA 510(k) clearance K946229 · decided 1995-08-04
Clearance details
- K-number
- K946229
- Device name
- BALANCE MANAGER
- Applicant
- Neurocom International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-12-22
- Decision date
- 1995-08-04
- Days to decision
- 225 days
- Clearance type
- Traditional
- Product code
- KHX
- Device class
- 1
- Regulation number
- 890.1575
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Clackamas, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.