FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Reusable NIBP Cuff
K Number: K191253
·
Decision Sep 17, 2019
Classifications
1
FEI Numbers
172
Registration Numbers
172
Same Product Code
197
Applicant Total
8
Review Days
131
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Reusable NIBP Cuff
- K Number
- K191253
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1120
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shenzhen Changke Connect Electronics Co., Ltd.
- Date Received
- May 9, 2019
- Decision Date
- September 17, 2019
- Product Code
- DXQ
- 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 |
|---|---|---|---|
| DXQ | Blood Pressure Cuff | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DXQ), ordered by most recent decision date.
YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff
FDA 510(k)
FDA Class 2
·Cardiovascular
NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)
FDA 510(k)
FDA Class 2
·Cardiovascular
Disposable Neonatal NIBP Cuff (U1681S-C51N)
FDA 510(k)
FDA Class 2
·Cardiovascular
Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)
FDA 510(k)
FDA Class 2
·Cardiovascular
AViTA Arm Type Blood Pressure Monitor Cuff
FDA 510(k)
FDA Class 2
·Cardiovascular
Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Shenzhen Changke Connect Electronics Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K213884 | Disposable EEG cable | May 6, 2022 | Substantially Equivalent |
| K193625 | Disposable Temperature Probe | Jul 24, 2020 | Substantially Equivalent |
| K200026 | Disposable ECG Cable | May 12, 2020 | Substantially Equivalent |
| K193629 | Disposable NIBP Cuff | Mar 25, 2020 | Substantially Equivalent |
| K200069 | Disposable SpO2 Sensor | Mar 13, 2020 | Substantially Equivalent |
| K191428 | ECG Cable | Nov 27, 2019 | Substantially Equivalent |
| K191420 | Reusable SpO2 Sensor | Oct 11, 2019 | Substantially Equivalent |