510(k) K062692 ยท GXY Electrode, Cutaneous
BIS BILATERAL SENSOR
| Applicant | Aspect Medical Systems, Inc., Newton MA, US |
| Decision | Substantially Equivalent, Dec 13, 2006 |
| Received | Sep 11, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K062692
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 26, 2012 | Nellcor Puritan Bennett Inc. (dba Covidien LP) BIS Bilateral Sensors, part number 186-0212, packaged in boxes of 10. For use with BIS Monitoring System, Labeled as either Covidien Llc, or Aspect Medical Systems, Inc.
Product Usage:
To enable rec Terminated |
GXY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.