FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIENT MONITORS, RELEASE B.O.
K Number: K032858
·
Decision Oct 10, 2003
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
397
Applicant Total
12
Review Days
28
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Basic Information
- Device Name
- THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIENT MONITORS, RELEASE B.O.
- K Number
- K032858
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Philips Medizin Systeme Boblingen GmbH
- Date Received
- September 12, 2003
- Decision Date
- October 10, 2003
- Product Code
- DSI
- 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 |
|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | FDA class 2 | Cardiovascular |
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