FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODEL UB-328
K Number: K040229
·
Decision Mar 19, 2004
Classifications
1
FEI Numbers
428
Registration Numbers
428
Same Product Code
1216
Applicant Total
34
Review Days
46
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Basic Information
- Device Name
- A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODEL UB-328
- K Number
- K040229
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- A&D Engineering, Inc.
- Date Received
- February 2, 2004
- Decision Date
- March 19, 2004
- 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 A&D Engineering, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K082734 | A&D MEDICAL UA-851THW DIGITAL BLOOD PRESSURE MONITOR | Nov 13, 2008 | Substantially Equivalent |
| K062027 | A&D MEDICAL UA-789 DIGITAL BLOOD PRESSURE MONITOR | Jan 19, 2007 | Substantially Equivalent |
| K061456 | A & D MEDICAL UM-101 DIGITAL BLOOD PRESSURE MONITOR | Jun 21, 2006 | Substantially Equivalent |
| K043217 | A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITOR | Mar 3, 2005 | Substantially Equivalent |
| K042967 | A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODELS UB-511 & UB-512 | Dec 3, 2004 | Substantially Equivalent |
| K040371 | A & D MEDICAL UA-767BT DIGITAL BLOOD PRESSURE MONITOR | May 19, 2004 | Substantially Equivalent |
| K032499 | A & D MEDICAL LIFESOURCE UA-704 DIGITAL BLOOD PRESSURE MONITORS | Oct 30, 2003 | Substantially Equivalent |
| K012472 | A & D MEDICAL LIFESOURCE UA-781, UA781PC, & UA-781T DIGITAL BLOOD PRESSURE MONITORS | Feb 15, 2002 | Substantially Equivalent |
| K012013 | LIFESOURCE MODELS UA-787, UA 787PC, UA-787T | Jul 13, 2001 | Substantially Equivalent |
| K010828 | DIGITAL BLOOD PRESSURE MONITORS, MODELS TM-2655, TM-2655P, & TM-2655VP | Mar 29, 2001 | Substantially Equivalent |