FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Electronic Blood Pressure Monitor, model: HTD6602US
K Number: K223170
·
Decision Dec 5, 2023
Classifications
1
FEI Numbers
428
Registration Numbers
428
Same Product Code
1216
Applicant Total
8
Review Days
420
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Basic Information
- Device Name
- Electronic Blood Pressure Monitor, model: HTD6602US
- K Number
- K223170
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hetaida Technology Co., Ltd.
- Date Received
- October 11, 2022
- Decision Date
- December 5, 2023
- 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 Hetaida Technology Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K243661 | Electronic Blood Pressure Monitor | Feb 7, 2025 | Substantially Equivalent |
| K241202 | Electric nasal aspirator (HTD2601US) | Jul 1, 2024 | Substantially Equivalent |
| K203332 | Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C | Feb 25, 2021 | Substantially Equivalent |
| K200159 | Non-contact Infrared Body Thermometer, model:HTD8823US | Jan 5, 2021 | Substantially Equivalent |
| K180387 | Infrared Ear Thermometer | Jan 10, 2019 | Substantially Equivalent |
| K171888 | Non-contact infrared body thermometer | Jul 23, 2018 | Substantially Equivalent |
| K180385 | Infrared Body Thermometer | May 11, 2018 | Substantially Equivalent |