510(k) K940151 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
ULTRASOUND PROBE DRAPE
| Applicant | Hydro-Med Products, Inc., Dallas TX, US |
| Decision | Substantially Equivalent, Nov 14, 1994 |
| Received | Jan 3, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K940151
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 6, 2005 | Hydro Med Products, Inc Ultrasound Probe Drape Tapered to 1.5' Sterile 8' x 60', Product Number 781-983; Manufactured by Hydo-Med Products Inc., 2930 Ladybird Ln., Dallas, TX 75220 Terminated |
MMP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.