The following data is part of a premarket notification filed by Sonomed Technology, Inc. with the FDA for Clear Image Sterile Diagnostic Ultrsound Gel.
| Device ID | K931909 |
| 510k Number | K931909 |
| Device Name: | CLEAR IMAGE STERILE DIAGNOSTIC ULTRSOUND GEL |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | SONOMED TECHNOLOGY, INC. P.O. BOX 10489 State College, PA 16805 |
| Contact | Margaret J Larson |
| Correspondent | Margaret J Larson SONOMED TECHNOLOGY, INC. P.O. BOX 10489 State College, PA 16805 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-16 |
| Decision Date | 1994-09-29 |