Tempus ECG-AF— 510(k) K233549
Substantially EquivalentTempus AI, Inc.
FDA 510(k) clearance K233549 for Tempus ECG-AF, Substantially Equivalent on 2024-06-21. Applicant: Tempus AI, Inc.. Device class: 2.
Clearance details
- Applicant
- Tempus AI, Inc.
- Product code
- Code SBQ
- Device class
- Class 2
- Regulation
- 21 CFR 870.2380
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chicago, IL, US
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