FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR, MODEL CARDIOCARE 1000I
K Number: K021225
·
Decision May 22, 2002
Classifications
1
FEI Numbers
428
Registration Numbers
428
Same Product Code
1216
Applicant Total
16
Review Days
34
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Basic Information
- Device Name
- ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR, MODEL CARDIOCARE 1000I
- K Number
- K021225
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Rossmax International , Ltd.
- Date Received
- April 18, 2002
- Decision Date
- May 22, 2002
- 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 Rossmax International , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K060342 | ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR MODEL MO701K | Apr 4, 2006 | Substantially Equivalent |
| K052727 | ROSSMAX NON-INVASIVE BLOOD PRESSURE MONITORS, MODELS S380, K350 | Dec 16, 2005 | 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 |