TBI TRAINER— 510(k) K840837
Substantially EquivalentManico
FDA 510(k) clearance K840837 for TBI TRAINER, Substantially Equivalent on 1985-03-25. Applicant: Manico. Device class: 1.
Clearance details
- Applicant
- Manico
- Product code
- Code FEJ
- Device class
- Class 1
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.