BE MICRO, TREA
FDA 510(k) clearance K093728 · decided 2010-04-29
Clearance details
- K-number
- K093728
- Device name
- BE MICRO, TREA
- Applicant
- Eb Neuro S.P.A.
- Decision
- Substantially Equivalent
- Date received
- 2009-12-03
- Decision date
- 2010-04-29
- Days to decision
- 147 days
- Clearance type
- Traditional
- Product code
- OLV
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Carmel, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.