TD50 ELECTROMYOGRAPH
FDA 510(k) clearance K935017 · decided 1994-07-28
Clearance details
- K-number
- K935017
- Device name
- TD50 ELECTROMYOGRAPH
- Applicant
- Medelec Intl. Corp.
- Decision
- Substantially Equivalent
- Date received
- 1993-10-19
- Decision date
- 1994-07-28
- Days to decision
- 282 days
- Clearance type
- Traditional
- Product code
- JXE
- Device class
- 2
- Regulation number
- 882.1550
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- England, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.