510(k) K873580
K873580 is an FDA 510(k) premarket notification submitted by Medical High Technology International, Inc. for the device "MHTI CT-SIM RADIATION THERAPY TREATMENT SIMULATOR". The FDA issued a decision of Substantially Equivalent on Nov 2, 1987. The device falls under product code KPQ (System, Simulation, Radiation Therapy), a Class II device regulated under 21 CFR 892.5840.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 2, 1987
- Date Received
- Aug 27, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, Simulation, Radiation Therapy
- Device Class
- Class II
- Regulation Number
- 892.5840
- Review Panel
- RA
- Submission Type
- 510(k)