CN-Suite— 510(k) K260563
Substantially EquivalentFIND Surgical Sciences Inc. D/B/A FIND Neuro
FDA 510(k) clearance K260563 for CN-Suite, Substantially Equivalent on 2026-08-16. Applicant: FIND Surgical Sciences Inc. D/B/A FIND Neuro. Device class: 2.
Summary
FIND Surgical Sciences, doing business as FIND Neuro, filed CN-Suite under product code OLX, source localization software for electroencephalograph or magnetoencephalograph. The record doesn't expand CN.
Class II, 21 CFR 882.1400. Neurology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
FIND filed from Cambridge, Massachusetts. The decision came 178 calendar days after FDA received it (February 19 to August 16, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- FIND Surgical Sciences Inc. D/B/A FIND Neuro
- Product code
- Product code OLX
- Device class
- Class 2
- Regulation
- 21 CFR 882.1400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cambridge, MA, US
Recent devices under product code OLX
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