PreemptiveAI Clinical SDK— 510(k) K250233
Substantially EquivalentMeasure Labs, Inc. (Dba Preemptiveai, Inc.)
FDA 510(k) clearance K250233 for PreemptiveAI Clinical SDK, Substantially Equivalent on 2026-02-13. Applicant: Measure Labs, Inc. (Dba Preemptiveai, Inc.). Device class: 2.
Clearance details
- Applicant
- Measure Labs, Inc. (Dba Preemptiveai, Inc.)
- Product code
- Code DXH
- Device class
- Class 2
- Regulation
- 21 CFR 870.2920
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seattle, WA, US
Recent devices under product code DXH
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