FDA Product Code
FDA Product Code MLD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1025
510(k) Clearances — 14 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K101602 | VITAL SIGNS MONITOR | Criticare Systems, Inc. | 2010-09-01 | Special | PDF ↗ |
| K080461 | STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0 | Philips Medical Systems | 2008-03-13 | Special | PDF ↗ |
| K022740 | DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE | Datex-Ohmeda | 2002-11-14 | Traditional | PDF ↗ |
| K012837 | MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES | Datex-Ohmeda | 2001-09-14 | Special | PDF ↗ |
| K002105 | SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS | Siemens Medical Solutions USA, Inc. | 2000-12-05 | Traditional | PDF ↗ |
| K992323 | DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES | Datex-Ohmeda, Inc. | 1999-11-01 | Traditional | PDF ↗ |
| K982104 | ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500 | Medical Data Electronics | 1998-11-25 | Special | PDF ↗ |
| K974492 | SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYSIS | Siemens Medical Solutions USA, Inc. | 1998-02-26 | Traditional | PDF ↗ |
| K972121 | ACUITY CENTRAL STATION | Protocol Systems, Inc. | 1997-11-07 | Traditional | PDF ↗ |
| K953175 | AS/3 ESTPR MODULE | Datex Division Instrumentarium Corp. | 1997-02-06 | Traditional | PDF ↗ |
| K960272 | EAGLE 3000/3100 PATIENT MONITOR | Marquette Electronics, Inc. | 1996-10-02 | Traditional | PDF ↗ |
| K960934 | HP M1205A OMNICARE COMPONENT MONITOR SYSTEM MODEL 24 | Hewlett-Packard Co. | 1996-06-14 | Traditional | PDF ↗ |
| K935020 | OMNI-TRAC MODIFICATION | Invivo Research, Inc. | 1995-04-26 | Traditional | PDF ↗ |
| K920429 | MODIFIED MODEL M1403A TELEMETRY MONITORING SYSTEM | Hewlett-Packard Co. | 1993-07-20 | Traditional | PDF ↗ |
Product code MLD · Class II · Cardiovascular. Data: openFDA.