MSB (ELECTRICAL STIMULATION) ELECTRODES (DISPOSABLE). (TENS/FES/NMES)
FDA 510(k) clearance K990370 · decided 1999-04-12
Clearance details
- K-number
- K990370
- Device name
- MSB (ELECTRICAL STIMULATION) ELECTRODES (DISPOSABLE). (TENS/FES/NMES)
- Applicant
- Msb,Uk
- Decision
- Substantially Equivalent
- Date received
- 1999-02-08
- Decision date
- 1999-04-12
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- GXY
- Device class
- 2
- Regulation number
- 882.1320
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Marlborough,Wiltshire, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.