FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
A&D UB-322 WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR
K Number: K980824
·
Decision Mar 19, 1998
Classifications
1
FEI Numbers
420
Registration Numbers
420
Same Product Code
1186
Applicant Total
34
Review Days
15
Basic Information
- Device Name
- A&D UB-322 WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR
- K Number
- K980824
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- A & D ENGINEERING, INC.
- Date Received
- March 4, 1998
- Decision Date
- March 19, 1998
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DXN), ordered by most recent decision date.
G0 Blood Pressure Monitoring System (G0)
FDA 510(k)
FDA Class 2
·Cardiovascular
Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)
FDA 510(k)
FDA Class 2
·Cardiovascular
Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist Bloo
FDA 510(k)
FDA Class 2
·Cardiovascular
Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blood Pressure Monitor (ARM-30E+);
FDA 510(k)
FDA Class 2
·Cardiovascular
Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Blood Pressure Monitor (ARM-90B)
FDA 510(k)
FDA Class 2
·Cardiovascular
Globalcare Blood Pressure Monitor (GUS610)
FDA 510(k)
FDA Class 2
·Cardiovascular
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 |
| K040229 | A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODEL UB-328 | Mar 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 |