510(k) K132604 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
| Applicant | Covidien, Boulder CO, US |
| Decision | Substantially Equivalent, Dec 4, 2013 |
| Received | Aug 20, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K132604
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2014 | Nellcor Puritan Bennett Inc. (dba Covidien LP) Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box.
The Vital Sync Virtual Pat Terminated |
MWI | None listed |
| Aug 14, 2014 | Nellcor Puritan Bennett Inc. (dba Covidien LP) Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box.
The Vital Sync Virtua Terminated |
MWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.