FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Cleerly ISCHEMIA
K Number: K231335
·
Decision Sep 8, 2023
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
4
Review Days
123
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Basic Information
- Device Name
- Cleerly ISCHEMIA
- K Number
- K231335
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cleerly, Inc.
- Date Received
- May 8, 2023
- Decision Date
- September 8, 2023
- Product Code
- QXZ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QXZ | Adjunctive Epicardial Vascular Physiologic Status Indicator | FDA class 2 | Cardiovascular |