The following data is part of a premarket notification filed by Numa, Inc. with the FDA for Numastation.
| Device ID | K974444 |
| 510k Number | K974444 |
| Device Name: | NUMASTATION |
| Classification | System, Tomography, Computed, Emission |
| Applicant | NUMA, INC. 10 NORTHERN BLVD., UNIT 12 Amherst, NH 03031 |
| Contact | Kurt N Larson |
| Correspondent | Kurt N Larson NUMA, INC. 10 NORTHERN BLVD., UNIT 12 Amherst, NH 03031 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-25 |
| Decision Date | 1998-02-13 |
| Summary: | summary |