DIGITAL ELECTRONEUROMETER S-100
FDA 510(k) clearance K843924 · decided 1985-03-12
Clearance details
- K-number
- K843924
- Device name
- DIGITAL ELECTRONEUROMETER S-100
- Applicant
- Neurotron, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-10-05
- Decision date
- 1985-03-12
- Days to decision
- 158 days
- Clearance type
- Traditional
- Product code
- JXE
- Device class
- 2
- Regulation number
- 882.1550
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Lawrenceville, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.