FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT
K Number: K041674
·
Decision Jul 19, 2004
Classifications
1
FEI Numbers
400
Registration Numbers
400
Same Product Code
725
Applicant Total
107
Review Days
28
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Basic Information
- Device Name
- THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT
- K Number
- K041674
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Philips Medical Systems
- Date Received
- June 21, 2004
- Decision Date
- July 19, 2004
- Product Code
- DQA
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| DQA | Oximeter | FDA class 2 | Cardiovascular |
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