510(k) K843366
K843366 is an FDA 510(k) premarket notification submitted by Scanditronix, Inc. for the device "SUPERPETT". The FDA issued a decision of Substantially Equivalent on November 21, 1984. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. Scanditronix, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 21, 1984
- Date Received
- August 28, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Tomography, Computed, Emission
- Device Class
- Class II
- Regulation Number
- 892.1200
- Review Panel
- RA
- Submission Type