FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL BP-3BTO-AP
K Number: K041411
·
Decision Jul 21, 2004
Classifications
1
FEI Numbers
420
Registration Numbers
420
Same Product Code
1186
Applicant Total
13
Review Days
55
Basic Information
- Device Name
- MICROLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL BP-3BTO-AP
- K Number
- K041411
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MICROLIFE CORP.
- Date Received
- May 27, 2004
- Decision Date
- July 21, 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 MICROLIFE CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K122013 | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, CARDIO+ (BP4GAPO-2M) | May 13, 2013 | Substantially Equivalent |
| K080337 | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MQ1-2D | May 13, 2008 | Substantially Equivalent |
| K073398 | MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3MK1-3 (BP W100) | Dec 20, 2007 | Substantially Equivalent |
| K073397 | MICROLIFE UPPER ARM MANUAL BLOOD PRESSURE MONITOR, MODEL BP3MR1-H (BP A50) | Dec 20, 2007 | Substantially Equivalent |
| K031024 | MICROLIFE ELECTRONIC PEAK FLOW MONITOR, MODEL PF-100 | Nov 14, 2003 | Substantially Equivalent |
| K030961 | MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921 | Sep 12, 2003 | Substantially Equivalent |
| K021305 | MICROLIFE WRIST WATCH BLOOD PRESSURE, MODEL BP-3BU1-5, WITH OPTIONAL THERMAL PRINTER | Jun 28, 2002 | Substantially Equivalent |
| K020725 | MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1 | Mar 12, 2002 | Substantially Equivalent |
| K013485 | MICROLIFE UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP-3BTO-1, WITH OPTIONAL THERMAL PRINTER, MODEL PR 1KA1 | Jan 17, 2002 | Substantially Equivalent |
| K003308 | MICROLIFE DIGITAL INFRARED EAR THERMOMETER, IR1DAI, IR1DB1, IR1DD1 | Nov 14, 2000 | Substantially Equivalent |