Deterioration Index Version 2— 510(k) K260008
Substantially EquivalentEpic Systems Corporation
FDA 510(k) clearance K260008 for Deterioration Index Version 2, Substantially Equivalent on 2026-09-18. Applicant: Epic Systems Corporation. Device class: 2.
Summary
Deterioration Index Version 2 is from Epic Systems Corporation, filed under product code QNL (Medium-Term Adjunctive Predictive Cardiovascular Indicator). The record doesn't describe the device's inputs or outputs.
Class II, 21 CFR 870.2210. Cardiovascular is both the classification panel and the review panel. It was a Traditional 510(k), decided Substantially Equivalent.
Epic filed from Verona, Wisconsin. The decision came 259 calendar days after receipt (January 2 to September 18, 2026).
Clearance details
- Applicant
- Epic Systems Corporation
- Product code
- Product code QNL
- Device class
- Class 2
- Regulation
- 21 CFR 870.2210
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Verona, WI, US
Recent devices under product code QNL
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