The following data is part of a premarket notification filed by Cilco, Inc. with the FDA for Cilco Sonometrics A&b Digital System (digiscan).
| Device ID | K854969 |
| 510k Number | K854969 |
| Device Name: | CILCO SONOMETRICS A&B DIGITAL SYSTEM (DIGISCAN) |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | CILCO, INC. 1616 13TH. AVE. SUITE 200 Huntington, WV 25701 |
| Contact | Terry C Mcmahon |
| Correspondent | Terry C Mcmahon CILCO, INC. 1616 13TH. AVE. SUITE 200 Huntington, WV 25701 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-11 |
| Decision Date | 1986-02-27 |