The following data is part of a premarket notification filed by Parker Laboratories, Inc. with the FDA for Aquasonic 100 Ultrasound Trans. Gel,.
| Device ID | K802146 |
| 510k Number | K802146 |
| Device Name: | AQUASONIC 100 ULTRASOUND TRANS. GEL, |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | PARKER LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-05 |
| Decision Date | 1980-10-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855683006005 | K802146 | 000 |