TYTRON C-3000
FDA 510(k) clearance K974208 · decided 1998-02-03
Clearance details
- K-number
- K974208
- Device name
- TYTRON C-3000
- Applicant
- Titronics Research & Development Co.
- Decision
- Substantially Equivalent
- Date received
- 1997-11-10
- Decision date
- 1998-02-03
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- HCS
- Device class
- 2
- Regulation number
- 882.1570
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Oxford, IA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.