FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
M2376A PHILIPS DEVICE LINK SYSTEM
K Number: K033680
·
Decision Dec 11, 2003
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
305
Applicant Total
107
Review Days
17
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Basic Information
- Device Name
- M2376A PHILIPS DEVICE LINK SYSTEM
- K Number
- K033680
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Philips Medical Systems
- Date Received
- November 24, 2003
- Decision Date
- December 11, 2003
- Product Code
- MWI
- 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 |
|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | FDA class 2 | Cardiovascular |
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