510(k) K134046 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR
| Applicant | Fukuda Denshi USA, Inc., Redmond WA, US |
| Decision | Substantially Equivalent, Feb 12, 2015 |
| Received | Dec 31, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K134046
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2017 | Fukuda Denshi Co., Ltd. Fukuda Denshi patient monitor model DS-8100M and DS-8100N
Product Usage:
Use of the Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is indicated in those situations where observation of Completed |
MHX | None listed |
| Jan 16, 2016 | Fukuda Denshi USA, Inc. Fukuda Denshi patient monitor model DS-8100M and DS-8100N.
The Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is
meant to acquire and monitor physiological signals from patients. Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.