510(k) K031169 ยท FFX System, Gastrointestinal Motility (Electrical)
MOTILITY VISUALIZATION SYSTEM
| Applicant | Sierra Scientific Instruments, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Dec 12, 2003 |
| Received | Apr 14, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031169
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2011 | Sierra Scientific Instruments Inc AR ManoShield, MSS-3599, 10 pack.
FGS: MSS-3599,
Individual package label: LBL-110275-03,
Box label: LBL-110282-03,
Package Inserts: DOC-3682,
User Manual: DOC-1332-12.
Product Usage: The MVS disp Terminated |
FFX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.