FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Holter ECG and ABP System
K Number: K230184
·
Decision Sep 25, 2023
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
193
Applicant Total
92
Review Days
245
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Basic Information
- Device Name
- Holter ECG and ABP System
- K Number
- K230184
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Edan Instruments, Inc.
- Date Received
- January 23, 2023
- Decision Date
- September 25, 2023
- Product Code
- DSH
- 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 |
|---|---|---|---|
| DSH | Recorder, Magnetic Tape, Medical | FDA class 2 | Cardiovascular |
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Other Clearances by Edan Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251591 | Holter ECG and ABP system (HolterABP) | Feb 9, 2026 | Substantially Equivalent |
| K251268 | Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) | Dec 23, 2025 | Substantially Equivalent |
| K241882 | Fetal & Maternal Monitor (F15A, F15A Air) | Aug 27, 2025 | Substantially Equivalent |
| K250179 | Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) | Jul 29, 2025 | Substantially Equivalent |
| K250214 | Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88) | Feb 20, 2025 | Substantially Equivalent |
| K240320 | Patient Monitor (RespArray) | Jun 28, 2024 | Substantially Equivalent |
| K232786 | Stimulation System (PA series, PR series, S series and Q series) | May 16, 2024 | Substantially Equivalent |
| 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 |