510(k) K020436 ยท IZL System, X-Ray, Mobile
PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.0
| Applicant | Sedecal., Sa., Deer Field IL, US |
| Decision | Substantially Equivalent, Feb 22, 2002 |
| Received | Feb 8, 2002 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K020436
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 29, 2003 | Sedecal USA, Inc Sedecal SP-HF 4.0 Portable X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) Spain Terminated |
IZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.