MLD · Monitor, St Segment With Alarm
Cardiovascular · 21 CFR 870.1025 · Class 2
Overview
| Product Code | MLD |
|---|---|
| Device Name | Monitor, St Segment With Alarm |
| Regulation | 21 CFR 870.1025 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.
Classification Rationale
Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
Recent Cleared Devices (14 of 14)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K101602 | VITAL SIGNS MONITOR | Criticare Systems, Inc. | Sep 1, 2010 | SESE |
| K080461 | STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0 | Philips Medical Systems | Mar 13, 2008 | SESE |
| K022740 | DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE | Datex-Ohmeda | Nov 14, 2002 | SESE |
| K012837 | MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES | Datex-Ohmeda | Sep 14, 2001 | SESE |
| K002105 | SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS | Siemens Medical Solutions USA, Inc. | Dec 5, 2000 | SESE |
| K992323 | DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES | Datex-Ohmeda, Inc. | Nov 1, 1999 | SESE |
| K982104 | ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500 | Medical Data Electronics | Nov 25, 1998 | SESE |
| K974492 | SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYSIS | Siemens Medical Solutions USA, Inc. | Feb 26, 1998 | SESE |
| K972121 | ACUITY CENTRAL STATION | Protocol Systems, Inc. | Nov 7, 1997 | SESE |
| K953175 | AS/3 ESTPR MODULE | Datex Division Instrumentarium Corp. | Feb 6, 1997 | SESE |
| K960272 | EAGLE 3000/3100 PATIENT MONITOR | Marquette Electronics, Inc. | Oct 2, 1996 | SESE |
| K960934 | HP M1205A OMNICARE COMPONENT MONITOR SYSTEM MODEL 24 | Hewlett-Packard Co. | Jun 14, 1996 | SESE |
| K935020 | OMNI-TRAC MODIFICATION | Invivo Research, Inc. | Apr 26, 1995 | SESE |
| K920429 | MODIFIED MODEL M1403A TELEMETRY MONITORING SYSTEM | Hewlett-Packard Co. | Jul 20, 1993 | SESE |
Top Applicants
- Datex-Ohmeda — 2 clearances
- Hewlett-Packard Co. — 2 clearances
- Siemens Medical Solutions USA, Inc. — 2 clearances
- Criticare Systems, Inc. — 1 clearance
- Datex Division Instrumentarium Corp. — 1 clearance
