FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR MODEL MO701K
K Number: K060342
·
Decision Apr 4, 2006
Classifications
1
FEI Numbers
428
Registration Numbers
428
Same Product Code
1216
Applicant Total
16
Review Days
53
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR MODEL MO701K
- K Number
- K060342
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Rossmax International , Ltd.
- Date Received
- February 10, 2006
- Decision Date
- April 4, 2006
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DXN), ordered by most recent decision date.
Wrist Blood Pressure Monitor (XW-05)
FDA 510(k)
FDA Class 2
·Cardiovascular
VicorderCS (VCS-SYS-1100)
FDA 510(k)
FDA Class 2
·Cardiovascular
Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)
FDA 510(k)
FDA Class 2
·Cardiovascular
Upper arm electronic blood pressure monitor (XB-01)
FDA 510(k)
FDA Class 2
·Cardiovascular
Blood Pressure Monitor (W06LT)
FDA 510(k)
FDA Class 2
·Cardiovascular
Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Rossmax International , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K052727 | ROSSMAX NON-INVASIVE BLOOD PRESSURE MONITORS, MODELS S380, K350 | Dec 16, 2005 | Substantially Equivalent |
| K021225 | ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR, MODEL CARDIOCARE 1000I | May 22, 2002 | Substantially Equivalent |
| K013539 | ROSSMAX MEDIPRO, MODELS 100F, 200F, AND 300F BLOOD PRESSURE MONITORS | Jan 17, 2002 | Substantially Equivalent |
| K013583 | ROSSMAX MEDIPRO MODEL 10 AND 60, MEDICARE MODEL 10 AND 60 BLOOD PRESSURE MONITORS | Jan 17, 2002 | Substantially Equivalent |
| K011352 | ROSSMAX SMARTINFLATE CARDIOPRO, MODEL 1000I AND MODEL 3000I BLOOD PRESSURE MONITORS | Jul 20, 2001 | Substantially Equivalent |
| K011539 | ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PRESSURE MONITORS | Jul 20, 2001 | Substantially Equivalent |
| K011523 | ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL BPW138 | Jun 14, 2001 | Substantially Equivalent |
| K993460 | ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z43 | Jan 11, 2000 | Substantially Equivalent |
| K993429 | ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z40 | Jan 7, 2000 | Substantially Equivalent |
| K993426 | ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z44 | Jan 7, 2000 | Substantially Equivalent |