B SMART MODEL 1
FDA 510(k) clearance K961817 · decided 1997-07-23
Clearance details
- K-number
- K961817
- Device name
- B SMART MODEL 1
- Applicant
- Koven Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-05-10
- Decision date
- 1997-07-23
- Days to decision
- 439 days
- Clearance type
- Traditional
- Product code
- LEL
- Device class
- 2
- Regulation number
- 882.5050
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.