FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
AT-Patch ECG Analysis System
K Number: K203638
·
Decision Oct 12, 2022
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
193
Applicant Total
2
Review Days
667
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Basic Information
- Device Name
- AT-Patch ECG Analysis System
- K Number
- K203638
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Atsens Co., Ltd.
- Date Received
- December 14, 2020
- Decision Date
- October 12, 2022
- 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 Atsens Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K242583 | AT-Patch (ATP-C130/ATP-C70) | May 2, 2025 | Substantially Equivalent |