510(k) K953673 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
ECLIPSE PROBE COVER
| Applicant | Parker Laboratories, Inc., Orange NJ, US |
| Decision | Substantially Equivalent, Mar 14, 1996 |
| Received | Aug 7, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953673
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 29, 2014 | Parker Laboratories, Inc. Parker Eclipse Probe Cover, Latex Free, REF 38-01, 10 Eclipse Probe Covers, Size: 2.37/1.75"W x 9.5"L (60/44 mm x 241 mm), Lot #D424, Expiry date 04/2016, Pre-gelled inside with Aquasonic 100 Ultrasou Terminated |
IYO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.