510(k) DEN250044
- Device
- STEMI AI ECG Model
- Applicant
- Powerful Medical, Inc.
- 510(k) number
- DEN250044
- Product code
- SHS
- Decision
- Unknown (DENG)
- Decision date
- 2026-09-03
- Date received
- 2025-09-22
- Review panel
- Unknown
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Arezou Azar
- Address
- 7th Floor, 33 W. 17th St. New York CA US 10011 10011
Source Documents#
510(k) summary PDF not indicated by FDA