510(k) K944495 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
MODEL 3200 VASCULAR MINI-LAB
| Applicant | Parks Medical Electronics, Inc., Aloha OR, US |
| Decision | Substantially Equivalent, Jun 2, 1995 |
| Received | Sep 13, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944495
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 10, 2012 | Parks Medical Electronics, Inc Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the devices are vascular blood flow machines. Devices are distributed with pressure cuffs of varying sizes as accessor Terminated |
DPW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.