510(k) K030613 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100
| Applicant | Criticare Systems, Inc., Waukesha WI, US |
| Decision | Substantially Equivalent, Apr 17, 2003 |
| Received | Feb 26, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K030613
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 22, 2026 | Criticare Technologies, Inc. nGenuity Patient Monitor with Capnography (ETCO2)
CAT 8100E1-ST-US, CAT 8100E1-US, CAT 8100EP1, CAT 8100EP1-ST, CAT 8100EP1-ST-US, CAT 8100EP1-US, CAT 8100EP1R Open, Classified |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.