FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
PG-800B SERIES, INCLUDING PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6
K Number: K131558
·
Decision Aug 30, 2013
Classifications
1
FEI Numbers
428
Registration Numbers
428
Same Product Code
1216
Applicant Total
9
Review Days
92
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Basic Information
- Device Name
- PG-800B SERIES, INCLUDING PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6
- K Number
- K131558
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shenzhen Pango Electronic Co., Ltd.
- Date Received
- May 30, 2013
- Decision Date
- August 30, 2013
- 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 |
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| K102988 | ELECTRONIC BLOOD PRESURE MONITOR | Nov 9, 2010 | Substantially Equivalent |
| K102920 | ELECTRONIC BLOOD PRESSURE MONITOR | Oct 15, 2010 | Substantially Equivalent |