← Product Code [SHS](/productcode/SHS) · DEN250044

# STEMI AI ECG Model (DEN250044)

_Powerful Medical, Inc. · SHS · Sep 3, 2026 · CV · DENG_

**Canonical URL:** https://fda.innolitics.com/device/DEN250044

## Device Facts

- **Applicant:** Powerful Medical, Inc.
- **Product Code:** [SHS](/productcode/SHS.md)
- **Decision Date:** Sep 3, 2026
- **Decision:** DENG
- **Submission Type:** Direct
- **Review Panel:** CV

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**Source:** [https://fda.innolitics.com/device/DEN250044](https://fda.innolitics.com/device/DEN250044)

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