Panels › Cardiovascular › Product code MLD · Class 2
Monitor, St Segment With Alarm
Regulation 870.1025
0510(k)s in 12 months (14 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in MLD
| Company | 510(k)s | Recalls |
|---|---|---|
| Datex-Ohmeda | 3 | 0 |
| GE Medical Systems Information Tecnology | 0 | 2 |
| Hewlett-Packard Co. | 2 | 0 |
| Siemens Medical Solutions USA, Inc. | 2 | 0 |
| Criticare Systems, Inc. | 1 | 0 |
| Datex Division Instrumentarium Corp. | 1 | 0 |
| Invivo Research, Inc. | 1 | 0 |
| Marquette Electronics, Inc. | 1 | 0 |
| Medical Data Electronics | 1 | 0 |
| Philips Medical Systems | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 1, 2009 | GE Medical Systems Information Tecnology Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software.
CCCM
Indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), res Terminated |
MLD | K022740 |
| Sep 1, 2009 | GE Medical Systems Information Tecnology Datex-Ohmeda S/5 Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software.
CCM
Indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respirato Terminated |
MLD | K022740 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.