510(k) K880047
K880047 is an FDA 510(k) premarket notification submitted by Huestis Machine Corp. for the device "HUESTIS COMPU-FORMER". The FDA issued a decision of Substantially Equivalent on Apr 11, 1988. The device falls under product code IXI (Block, Beam-Shaping, Radiation Therapy), a Class II device regulated under 21 CFR 892.5710. Huestis Machine Corp. has 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 11, 1988
- Date Received
- Jan 6, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Block, Beam-Shaping, Radiation Therapy
- Device Class
- Class II
- Regulation Number
- 892.5710
- Review Panel
- RA
- Submission Type
- 510(k)