FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
MEDITECH MODEL ABPM-04
K Number: K051149
·
Decision Nov 18, 2005
Classifications
1
FEI Numbers
428
Registration Numbers
428
Same Product Code
1216
Applicant Total
2
Review Days
198
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Basic Information
- Device Name
- MEDITECH MODEL ABPM-04
- K Number
- K051149
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Meditech Kft.
- Date Received
- May 4, 2005
- Decision Date
- November 18, 2005
- Product Code
- DXN
- 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | FDA class 2 | Cardiovascular |
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Other Clearances by Meditech Kft.
| K Number | Device Name | ||
|---|---|---|---|
| K071960 | MEDITECH AMBULATORY BLOOD PRESSURE MONITOR, MODEL ABPM-05 | Aug 3, 2007 | Substantially Equivalent |