510(k) K802146 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
AQUASONIC 100 ULTRASOUND TRANS. GEL,
| Applicant | Parker Laboratories, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Oct 10, 1980 |
| Received | Sep 5, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K802146
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 13, 2017 | Parker Laboratories, Inc. Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case Terminated |
IYO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.