MODEL 980D TENS NEUROPACER
FDA 510(k) clearance K792522 · decided 1979-12-13
Clearance details
- K-number
- K792522
- Device name
- MODEL 980D TENS NEUROPACER
- Applicant
- Empi
- Decision
- Substantially Equivalent
- Date received
- 1979-12-06
- Decision date
- 1979-12-13
- Days to decision
- 7 days
- Clearance type
- Traditional
- Product code
- GZJ
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.