510(k) K072286 ยท OLW Index-Generating Electroencephalograph Software
BIS EEG VISTA MONITOR SYSTEM AND BISX
| Applicant | Aspect Medical Systems, Inc., Norwood MA, US |
| Decision | Substantially Equivalent, Nov 20, 2007 |
| Received | Aug 16, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072286
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 26, 2018 | Covidien LLC Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems.
Product Number/CFN: 186-0208
UDI-Device Identifier (GTIN/UPN): 10884521130319 Open, Classified |
OLW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.