NURITE II VRM DUAL (ELEC. NERVE STIM.)
FDA 510(k) clearance K791834 · decided 1979-10-02
Clearance details
- K-number
- K791834
- Device name
- NURITE II VRM DUAL (ELEC. NERVE STIM.)
- Applicant
- Bio-Medical Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 1979-09-17
- Decision date
- 1979-10-02
- Days to decision
- 15 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.