FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Stimulation System (PA series, PR series, S series and Q series)
K Number: K232786
·
Decision May 16, 2024
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
547
Applicant Total
92
Review Days
248
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Basic Information
- Device Name
- Stimulation System (PA series, PR series, S series and Q series)
- K Number
- K232786
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Edan Instruments, Inc.
- Date Received
- September 11, 2023
- Decision Date
- May 16, 2024
- Product Code
- IPF
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | FDA class 2 | Physical Medicine |
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|---|---|---|---|
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| K240320 | Patient Monitor (RespArray) | Jun 28, 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 |
| K230184 | Holter ECG and ABP System | Sep 25, 2023 | Substantially Equivalent |