FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K WITH EASI-ST SEGMENT MEASUREMENT, HP VIRIDIA CMS 24/26, REV K WITH
K Number: K992595
·
Decision Dec 8, 1999
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
424
Applicant Total
16
Review Days
127
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Basic Information
- Device Name
- HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K WITH EASI-ST SEGMENT MEASUREMENT, HP VIRIDIA CMS 24/26, REV K WITH
- K Number
- K992595
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hewlett-Packard GmbH
- Date Received
- August 3, 1999
- Decision Date
- December 8, 1999
- Product Code
- MHX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | FDA class 2 | Cardiovascular |
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Other Clearances by Hewlett-Packard GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K993383 | HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.B | Feb 3, 2000 | Substantially Equivalent |
| K992273 | HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR M3000A/M3046A/M3016A,REL B | Jan 28, 2000 | Substantially Equivalent |
| K992674 | HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027A | Nov 8, 1999 | Substantially Equivalent |
| K990476 | HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, MODEL REV. K WITH EASI-ECG OPTION | Jul 22, 1999 | Substantially Equivalent |
| K991773 | HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE P | Jun 7, 1999 | Substantially Equivalent |
| K990972 | HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE T | Apr 19, 1999 | Substantially Equivalent |
| K990125 | HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K | Jan 29, 1999 | Substantially Equivalent |
| K981576 | MULTI-PARAMETER MODULE, MODEL M3000A & DISPLAY UNIT, MODEL M3046A | Jul 17, 1998 | Substantially Equivalent |
| K971910 | MULTI-PARAMETER MODULE (M3000A)/DISPLAY UNIT (M3046A) | Mar 23, 1998 | Substantially Equivalent |
| K973437 | HEWLETT-PACKARD MODELS M1001B ECG M1002B ECG/RESPIRATION PLUG-IN MODULES | Dec 3, 1997 | Substantially Equivalent |