510(k) K063419 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 )
| Applicant | Welch Allyn Protocol, Inc., Beaverton OR, US |
| Decision | Substantially Equivalent, Dec 4, 2006 |
| Received | Nov 13, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K063419
| 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.