Pulsenmore ES
FDA 510(k) clearance DEN240074 · decided 2025-10-31
Clearance details
- K-number
- DEN240074
- Device name
- Pulsenmore ES
- Applicant
- Pulsenmore, Ltd.
- Decision
- Unknown
- Date received
- 2024-12-11
- Decision date
- 2025-10-31
- Days to decision
- 324 days
- Clearance type
- Direct
- Product code
- SGJ
- Device class
- 2
- Regulation number
- 892.1590
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Omer, IL
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Pulsenmore
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
No recalls on record reference this clearance.