510(k) K053027 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300)
| Applicant | Welch Allyn, Inc., Skaneateles Falls NY, US |
| Decision | Substantially Equivalent, Nov 22, 2005 |
| Received | Oct 27, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K053027
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 30, 2009 | Welch Allyn Protocol, Inc Welch Allyn Vital Sign Monitor 5300 Series/Class II. (VSM 300).
The VSM300 can monitor systolic and diastolic noninvasive blood pressure (NIBP), pulse rate, and mean arterial pressure (MAP). Units co Terminated |
MWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.