FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Holter ECG and ABP system (HolterABP)
K Number: K251591
·
Decision Feb 9, 2026
Classifications
1
FEI Numbers
178
Registration Numbers
178
Same Product Code
429
Applicant Total
92
Review Days
262
Basic Information
- Device Name
- Holter ECG and ABP system (HolterABP)
- K Number
- K251591
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1425
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Edan Instruments, Inc.
- Date Received
- May 23, 2025
- Decision Date
- February 9, 2026
- Product Code
- DQK
- 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 |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | FDA class 2 | Cardiovascular |
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| K232962 | Patient Monitor (iX10, iX12, iX15) | Apr 19, 2024 | Substantially Equivalent |
| K233038 | Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s | Mar 8, 2024 | Substantially Equivalent |
| K232694 | Central Monitoring System (MFM-CMS) | Feb 5, 2024 | Substantially Equivalent |
| K230184 | Holter ECG and ABP System | Sep 25, 2023 | Substantially Equivalent |