NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT,
FDA 510(k) clearance K120853 · decided 2012-04-20
Clearance details
- K-number
- K120853
- Device name
- NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT,
- Applicant
- Bioness, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-03-21
- Decision date
- 2012-04-20
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- GZI
- Device class
- 2
- Regulation number
- 882.5810
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Valencia, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.