510(k) K862364 ยท HEM Imager, Ultrasonic Obstetric-Gynecologic
NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS)
| Applicant | Swemed Laboratories, Inc., Sweden, SE |
| Decision | Substantially Equivalent for Some Indications, Aug 19, 1986 |
| Received | Jun 24, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862364
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.