OJEMANN CORTICAL STIMULATOR
FDA 510(k) clearance K924226 · decided 1993-04-21
Clearance details
- K-number
- K924226
- Device name
- OJEMANN CORTICAL STIMULATOR
- Applicant
- Radionics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-08-21
- Decision date
- 1993-04-21
- Days to decision
- 243 days
- Clearance type
- Traditional
- Product code
- GYC
- Device class
- 2
- Regulation number
- 882.1310
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Burlington, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraopera recall (Z-1030-2013) | Integra Burlington MA, Inc. | 2013-04-01 |