FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM
K Number: K211127
·
Decision Sep 8, 2021
Classifications
1
FEI Numbers
428
Registration Numbers
428
Same Product Code
1216
Applicant Total
60
Review Days
145
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Basic Information
- Device Name
- Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM
- K Number
- K211127
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Health & Life Co., Ltd.
- Date Received
- April 16, 2021
- Decision Date
- September 8, 2021
- 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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| K Number | Device Name | ||
|---|---|---|---|
| K211744 | Non-Contact Infrared Thermometer, model HL710H | Nov 24, 2021 | Substantially Equivalent |
| K200521 | Full Automatic(NIBP) Blood Pressure Monitor | Jun 12, 2020 | Substantially Equivalent |
| K190507 | Full Automatic (NIBP) Blood Pressure Monitor | Sep 16, 2019 | Substantially Equivalent |
| K190133 | Full Automatic (NIBP) Blood Pressure Monitor-HL158UB | Jun 13, 2019 | Substantially Equivalent |
| K190134 | Full Automatic (NIBP) Blood Pressure Monitor-HL158TB | May 20, 2019 | Substantially Equivalent |
| K180240 | Full Automatic(NIBP) Blood Pressure Monitor | Oct 17, 2018 | Substantially Equivalent |
| K162338 | Full Automatic (NIBP) Blood Pressure Monitor | Sep 21, 2016 | Substantially Equivalent |
| K160557 | Full Automatic (NIBP) Blood Pressure Monitor | Jul 6, 2016 | Substantially Equivalent |
| K161156 | Full Automatic (NIBP) Blood Pressure Monitor | Jun 14, 2016 | Substantially Equivalent |
| K160336 | Full Automatic (NIBP) Blood Pressure Monitor | Mar 29, 2016 | Substantially Equivalent |