The following data is part of a premarket notification filed by Scanditronix, Inc. with the FDA for Superpett.
| Device ID | K843366 |
| 510k Number | K843366 |
| Device Name: | SUPERPETT |
| Classification | System, Tomography, Computed, Emission |
| Applicant | SCANDITRONIX, INC. P.O. BOX 3003 Newburyport, MA 01950 -0803 |
| Contact | Roy M Emanuelson |
| Correspondent | Roy M Emanuelson SCANDITRONIX, INC. P.O. BOX 3003 Newburyport, MA 01950 -0803 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-28 |
| Decision Date | 1984-11-21 |