510(k) K052160 ยท DSI Detector And Alarm, Arrhythmia
ACUITY CENTRAL STATION, MODEL 020XXXXX (NOTE: XXXXX = VARIOUS CONFIG.)
| Applicant | Welch Allyn, Inc., Skaneateles Falls NY, US |
| Decision | Substantially Equivalent, Dec 16, 2005 |
| Received | Aug 9, 2005 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K052160
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 3, 2011 | Welch Allyn Protocol, Inc Aruba Wireless Network Access Points, Model 65 utilized by the Acuity Central Monitoring System.
Welch Allyn Protocol, Inc.
Intended for use by clinicians for the central monitoring of neonatal, pedi Terminated |
DSI | None listed |
| Nov 12, 2010 | Welch Allyn Protocol, Inc ViewSonic 19" flat panel LCD display Model VG930M which is used as part of the Welch Allyn Acuity Central Monitoring System. The affected serial numbers are those less than QC2082880001.
The ViewSon Terminated |
DSI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.