EBI ACUMEN SURGICAL NAVIGATION SYSTEM
FDA 510(k) clearance K031732 · decided 2003-10-15
Clearance details
- K-number
- K031732
- Device name
- EBI ACUMEN SURGICAL NAVIGATION SYSTEM
- Applicant
- Ebi, L.P.
- Decision
- Substantially Equivalent
- Date received
- 2003-06-04
- Decision date
- 2003-10-15
- Days to decision
- 133 days
- Clearance type
- Traditional
- Product code
- HAW
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Parsippany, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SCOLITRON(TM) STIMULATOR (P820008/S005) | Ebi, L.P. | 1987-04-02 |
| SCOLITRON(TM) STIMULATOR (P820008/S004) | Ebi, L.P. | 1987-01-07 |
| SCOLITRON(TM) STIMULATOR (P820008/S003) | Ebi, L.P. | 1986-09-12 |
| SCOLITRON(TM) STIMULATOR (P820008/S002) | Ebi, L.P. | 1986-01-17 |
| SCOLITRON(TM) STIMULATOR (P820008/S001) | Ebi, L.P. | 1983-06-14 |
| SCOLITRON(TM) STIMULATOR (P820008) | Ebi, L.P. | 1983-01-06 |