FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIEN
K Number: K041741
·
Decision Jul 21, 2004
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
411
Applicant Total
111
Review Days
23
Basic Information
- Device Name
- M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIEN
- K Number
- K041741
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PHILIPS MEDICAL SYSTEMS, INC.
- Date Received
- June 28, 2004
- Decision Date
- July 21, 2004
- 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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|---|---|---|---|
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| K040955 | M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.01 AND INTELLIVUE CLINICAL NETWORK ON VLAN | May 12, 2004 | Substantially Equivalent |
| K040404 | HEARTSTART MRX, MODEL M3535A | May 4, 2004 | Substantially Equivalent |
| K040357 | M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.O AND THE M4840A TELEMETRY MONITORING SYSTEM II | Mar 3, 2004 | Substantially Equivalent |
| K032979 | PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T | Feb 20, 2004 | Substantially Equivalent |
| K033715 | PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER | Feb 13, 2004 | Substantially Equivalent |
| K033662 | SYNERGY SPINE ARRAY COIL | Feb 2, 2004 | Substantially Equivalent |