Product code MLD— Cardiovascular
ACUITY CENTRAL STATION
- Classification name
- Monitor, St Segment With Alarm
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Total cleared
- 14
- First cleared
- Most recent
Market context for product code MLD
FDA has cleared devices under product code MLD between 1993 and 2010, filed by 11 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2010
- 2008
- 2002
- 2001
- 2000
- 1999
- 1998
- 1997
- 1996
- 1995
- 1993
Top applicants under product code MLD
Recent clearances under product code MLD
- K101602 — VITAL SIGNS MONITOR
- K080461 — STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0
- K022740 — DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE
- K012837 — MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES
- K002105 — SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS
- K992323 — DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES
- K982104 — ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500
- K974492 — SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYSIS
- K972121 — ACUITY CENTRAL STATION
- K953175 — AS/3 ESTPR MODULE
- K960272 — EAGLE 3000/3100 PATIENT MONITOR
- K960934 — HP M1205A OMNICARE COMPONENT MONITOR SYSTEM MODEL 24
- K935020 — OMNI-TRAC MODIFICATION
- K920429 — MODIFIED MODEL M1403A TELEMETRY MONITORING SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.