Cleerly ISCHEMIA— 510(k) K231335
Substantially EquivalentCleerly, Inc.
FDA 510(k) clearance K231335 for Cleerly ISCHEMIA, Substantially Equivalent on 2023-09-08. Applicant: Cleerly, Inc.. Device class: 2.
Clearance details
- Applicant
- Cleerly, Inc.
- Product code
- Code QXZ
- Device class
- Class 2
- Regulation
- 21 CFR 870.2200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Denver, CO, US
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