MLD — Monitor, St Segment With Alarm Class II
FDA product code MLD covers "Monitor, St Segment With Alarm", a Class II medical device regulated under 21 CFR 870.1025. Submissions are reviewed by the Cardiovascular panel. At least 14 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MLD
- Device Class
- Class II
- Regulation Number
- 870.1025
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K101602 | criticare systems | VITAL SIGNS MONITOR | September 1, 2010 |
| K080461 | philips medical systems | STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0 | March 13, 2008 |
| K022740 | datex-ohmeda | DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWAR | November 14, 2002 |
| K012837 | datex-ohmeda | MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES | September 14, 2001 |
| K002105 | siemens medical solutions usa | SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS | December 5, 2000 |
| K992323 | datex-ohmeda | DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES | November 1, 1999 |
| K982104 | medical data electronics | ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500 | November 25, 1998 |
| K974492 | siemens medical solutions usa | SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYS | February 26, 1998 |
| K972121 | protocol systems | ACUITY CENTRAL STATION | November 7, 1997 |
| K953175 | datex division instrumentarium | AS/3 ESTPR MODULE | February 6, 1997 |
| K960272 | marquette electronics | EAGLE 3000/3100 PATIENT MONITOR | October 2, 1996 |
| K960934 | hewlett-packard | HP M1205A OMNICARE COMPONENT MONITOR SYSTEM MODEL 24 | June 14, 1996 |
| K935020 | invivo research | OMNI-TRAC MODIFICATION | April 26, 1995 |
| K920429 | hewlett-packard | MODIFIED MODEL M1403A TELEMETRY MONITORING SYSTEM | July 20, 1993 |