The following data is part of a premarket notification filed by Fathom Ent., Inc. with the FDA for Fathom Cmp-1000.
| Device ID | K930051 |
| 510k Number | K930051 |
| Device Name: | FATHOM CMP-1000 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | FATHOM ENT., INC. P.O. BOX 1311 Beckley, WV 25801 |
| Contact | Salvatore Pecoraro |
| Correspondent | Salvatore Pecoraro FATHOM ENT., INC. P.O. BOX 1311 Beckley, WV 25801 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-06 |
| Decision Date | 1993-07-20 |