FDA 510(k)
FDA class 2
Substantially Equivalent
🇭🇰 Hong Kong
BLOOD-PRESSURE METER
K Number: K021252
·
Decision Jun 17, 2002
Classifications
1
FEI Numbers
428
Registration Numbers
428
Same Product Code
1216
Applicant Total
6
Review Days
59
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Basic Information
- Device Name
- BLOOD-PRESSURE METER
- K Number
- K021252
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Idt Technology Limited
- Date Received
- April 19, 2002
- Decision Date
- June 17, 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 Idt Technology Limited
| K Number | Device Name | ||
|---|---|---|---|
| K151415 | Oregon Scientific | Oct 21, 2015 | Substantially Equivalent |
| K131245 | OREGON SCINTIFIC | Jan 17, 2014 | Substantially Equivalent |
| K050083 | BLOOD-PRESSURE METER, BPW120 | Apr 8, 2005 | Substantially Equivalent |
| K031167 | HIGH PRECISION BODY WEIGHT MONITOR WITH BODY FAT INDEX | Jan 28, 2004 | Substantially Equivalent |
| K020433 | FT101 FOREHEAD THERMOMETER; FT101 INFRARED DIGITAL THERMOMETER | Jul 11, 2002 | Substantially Equivalent |