510(k) K080461
- Device
- STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0
- Applicant
- PHILIPS MEDICAL SYSTEMS
- 510(k) number
- K080461
- Product code
- MLD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-03-13
- Date received
- 2008-02-20
- Regulation
- 870.1025
- Classification name
- Monitor, St Segment With Alarm
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ZETY BILLARD
- Address
- 3000 Minuteman Rd. Andover MA US 01810 01810
FDA Registration Numbers#
- 3003971136
- 3007413079
- 3005783425
- 3009077524
- 3009443693
- 3016701404
- 1316463
- 3013500228
- 3010157426
- 1218950
- 3012528160
- 3000126629
- 3016618143
- 9610816
- 2221819
- 1651104
- 3010390468
- 3032109181
- 3008729547
- 3008716327
- 3009499478
- 3014541700
- 1066270
- 3013679558
- 9610105
- 3007836437
- 3009156722
- 3013596024
- 3003857828
- 3001570235
- 1000122786
- 3012359877
- 9710602
- 3003263092
- 3006979678
- 3008483389
- 3004977335
- 3021559257
- 3012238587
- 3010703925
- 3007603826
- 3005877899
- 3009973336
- 3010838917
- 3010698831
- 3030733800
- 3007305624
- 3003589956
Source Documents#
Other 510(k) Records For Product Code MLD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K101602 | VITAL SIGNS MONITOR | Criticare Systems, Inc. | 2010-09-01 |
| K022740 | DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE | Datex-Ohmeda | 2002-11-14 |
| K012837 | MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES | Datex-Ohmeda | 2001-09-14 |
| K002105 | SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS | Siemens Medical Solutions USA, Inc. | 2000-12-05 |
| K992323 | DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES | Datex-Ohmeda, Inc. | 1999-11-01 |
| K982104 | ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500 | Medical Data Electronics | 1998-11-25 |
| K974492 | SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYSIS | Siemens Medical Solutions USA, Inc. | 1998-02-26 |
| K972121 | ACUITY CENTRAL STATION | Protocol Systems, Inc. | 1997-11-07 |
| K953175 | AS/3 ESTPR MODULE | Datex Division Instrumentarium Corp. | 1997-02-06 |
| K960272 | EAGLE 3000/3100 PATIENT MONITOR | Marquette Electronics, Inc. | 1996-10-02 |
| K960934 | HP M1205A OMNICARE COMPONENT MONITOR SYSTEM MODEL 24 | Hewlett-Packard Co. | 1996-06-14 |
| K935020 | OMNI-TRAC MODIFICATION | Invivo Research, Inc. | 1995-04-26 |
| K920429 | MODIFIED MODEL M1403A TELEMETRY MONITORING SYSTEM | Hewlett-Packard Co. | 1993-07-20 |
Legacy Summary#
summary
FDA Review#
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