FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-711AC
K Number: K052154
·
Decision Sep 8, 2005
Classifications
1
FEI Numbers
420
Registration Numbers
420
Same Product Code
1186
Applicant Total
54
Review Days
30
Basic Information
- Device Name
- OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-711AC
- K Number
- K052154
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- OMRON HEALTHCARE, INC.
- Date Received
- August 9, 2005
- Decision Date
- September 8, 2005
- Product Code
- DXN
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | FDA class 2 | Cardiovascular |
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