FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PATIENT MONITOR
K Number: K112190
·
Decision Nov 9, 2011
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
424
Applicant Total
10
Review Days
103
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Basic Information
- Device Name
- PATIENT MONITOR
- K Number
- K112190
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mediana Co., Ltd.
- Date Received
- July 29, 2011
- Decision Date
- November 9, 2011
- 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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