Cleerly ISCHEMIA
FDA 510(k) clearance K231335 · decided 2023-09-08
Clearance details
- K-number
- K231335
- Device name
- Cleerly ISCHEMIA
- Applicant
- Cleerly, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-05-08
- Decision date
- 2023-09-08
- Days to decision
- 123 days
- Clearance type
- Traditional
- Product code
- QXZ
- Device class
- 2
- Regulation number
- 870.2200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Denver, CO, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cleerly
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.