The following data is part of a premarket notification filed by The Reagents Of The University Of Michigan with the FDA for 3d-mspect.
| Device ID | K001026 |
| 510k Number | K001026 |
| Device Name: | 3D-MSPECT |
| Classification | System, Tomography, Computed, Emission |
| Applicant | THE REAGENTS OF THE UNIVERSITY OF MICHIGAN 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Sheila Hemeon-heyer |
| Correspondent | Sheila Hemeon-heyer THE REAGENTS OF THE UNIVERSITY OF MICHIGAN 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-30 |
| Decision Date | 2000-06-20 |