510(k) K250649
- Device
- Bunkerhill ECG-EF
- Applicant
- BunkerHill Health
- 510(k) number
- K250649
- Product code
- QYE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-09-19
- Date received
- 2025-03-04
- Regulation
- 870.2380
- Classification name
- Reduced Ejection Fraction Machine Learning-Based Notification Software
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Nishith Khandwala
- Address
- 436 Bryant St. San Francisco CA US 94107 94107
FDA Registration Numbers#
- 3013200421
- 3011651230
- 3027245002
- 3029762850
Source Documents#
Other 510(k) Records For Product Code QYE#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250652 | ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) | Anumana, Inc. | 2025-07-28 |
| K250119 | Tempus ECG-Low EF | Tempus AI, Inc. | 2025-07-15 |
| K233409 | Eko Low Ejection Fraction Tool (ELEFT) | Eko Health, Inc. | 2024-03-28 |
| K232699 | Low Ejection Fraction AI-ECG Algorithm | Anumana, Inc. | 2023-09-28 |