MODIFIED CONTACT-HEAT EVOKED POTENTIAL STIMULATOR (CHEPS)
FDA 510(k) clearance K051448 · decided 2005-06-29
Clearance details
- K-number
- K051448
- Device name
- MODIFIED CONTACT-HEAT EVOKED POTENTIAL STIMULATOR (CHEPS)
- Applicant
- Medoc Ltd. Advanced Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2005-06-02
- Decision date
- 2005-06-29
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- NTU
- Device class
- 2
- Regulation number
- 882.1870
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Somerset, MA, 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.
| Record | Firm | Date |
|---|---|---|
| PATHWAY - ATS/CHEPS (K052357) | Medoc Ltd. Advanced Medical Systems | 2006-01-19 |
| CONTACT HEAT-EVOKED POTENTIAL STIMULATOR (CHEPS) (K041908) | Medoc Ltd. Advanced Medical Systems | 2005-02-25 |
Recalls involving this device
No recalls on record reference this clearance.