ROTA DATAMATE I— 510(k) K935945
Substantially EquivalentRota Systems,Inc.
FDA 510(k) clearance K935945 for ROTA DATAMATE I, Substantially Equivalent on 1994-04-19. Applicant: Rota Systems,Inc.. Device class: 1.
Clearance details
- Applicant
- Rota Systems,Inc.
- Product code
- Code HMF
- Device class
- Class 1
- Regulation
- 21 CFR 886.1860
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Derby, KS, US
Recent devices under product code HMF
view allData sourced from openFDA. This site is unofficial and independent of the FDA.