The following data is part of a premarket notification filed by Stiefel Research Institute, Inc. with the FDA for Cusis Ultrasound Skin Imaging System.
| Device ID | K893996 |
| 510k Number | K893996 |
| Device Name: | CUSIS ULTRASOUND SKIN IMAGING SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | STIEFEL RESEARCH INSTITUTE, INC. Oak Hill, NY 12460 |
| Contact | William Carr |
| Correspondent | William Carr STIEFEL RESEARCH INSTITUTE, INC. Oak Hill, NY 12460 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-05 |
| Decision Date | 1989-09-21 |