510(k) K832950
K832950 is an FDA 510(k) premarket notification submitted by Scientific Manufacturer for the device "SCIENTRONICS 10K EYE MAGNET". The FDA issued a decision of Substantially Equivalent on October 19, 1983. The device falls under product code HPO (Magnet, Ac-Powered), a Class II device regulated under 21 CFR 886.4440.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 19, 1983
- Date Received
- August 31, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Magnet, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.4440
- Review Panel
- OP
- Submission Type