Cleerly ISCHEMIA— 510(k) K262839
Substantially EquivalentCleerly, Inc.
FDA 510(k) clearance K262839 for Cleerly ISCHEMIA, Substantially Equivalent on 2026-10-29. Applicant: Cleerly, Inc.. Device class: 2.
Clearance details
- Applicant
- Cleerly, Inc.
- Product code
- Product code QXZ
- Device class
- Class 2
- Regulation
- 21 CFR 870.2200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Denver, CO, US
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