K232823
- 510(k) number
- K232823
- Device name
- MCG-S (AM1000)
- Applicant
- Amcg Co., Ltd. KR
- Product code
- DPS — Electrocardiograph
- Decision date
- 2024-04-05
- Date received
- 2023-09-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K232823.pdf
Official FDA record: K232823
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.