510(k) K961757 ยท ITX Transducer, Ultrasonic, Diagnostic
ECOGEL 100 ULTRASOUND GEL
| Applicant | Eco-Med Pharmaceuticals, Inc., Mississauga, Ontario, CA |
| Decision | Substantially Equivalent, Jul 25, 1996 |
| Received | May 6, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961757
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2021 | AMTEC SALES Inc EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and EcoLotion Transmission Lotion
1) 100, 200 gel Intended for use in acoustic coupling of ultrasound Open, Classified |
ITX | None listed |
| Aug 11, 2021 | Red Medical Supplies EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU Open, Classified |
ITX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.