Saans (F4-01-00-000-000)— 510(k) K251165

Name: FDA 510(k) clearance K251165
Creator: U.S. Food and Drug Administration
Published: 2026-01-06

Substantially Equivalent

Innaccel Technologies Private Limited

FDA 510(k) clearance K251165 for Saans (F4-01-00-000-000), Substantially Equivalent on 2026-01-06. Applicant: Innaccel Technologies Private Limited. Device class: 2.

Clearance details

Applicant: Innaccel Technologies Private Limited
Product code: Code SGR
Device class: Class 2
Regulation: 21 CFR 868.5895
Advisory panel: Anesthesiology
Date received: 2025-04-15
Decision date: 2026-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bengaluru, IN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.