510(k) clearance
Deterioration Index Version 2
- 510(k) number
- K260008
- Applicant
- Epic Systems Corporation
- Decision date
- Sep 18, 2026
- Date received
- Jan 2, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- QNL
- Device type
- Medium-Term Adjunctive Predictive Cardiovascular Indicator
- Device class
- Class II
- Regulation
- 21 CFR 870.2210
- Advisory committee
- Cardiovascular
- Statement or summary
- Summary
- Third party
- N
- Location
- Verona, WI, US