The following data is part of a premarket notification filed by Cyberlogic, Inc. with the FDA for Ultrascan 650.
| Device ID | K161919 |
| 510k Number | K161919 |
| Device Name: | UltraScan 650 |
| Classification | Bone Sonometer |
| Applicant | CyberLogic, Inc. 611 Boradway, Suite 707 New York, NY 10012 |
| Contact | Jonathan J. Kaufman |
| Correspondent | Paul Dryden ProMedic, Inc. 24301 Woodsage Dr. Bonita Springs, FL 34134 |
| Product Code | MUA |
| CFR Regulation Number | 892.1180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-13 |
| Decision Date | 2017-04-05 |
| Summary: | summary |