BedDot (G1)— 510(k) K253274

Substantially Equivalent

Intelligent Dots, LLC

FDA 510(k) clearance K253274 for BedDot (G1), Substantially Equivalent on 2026-06-25. Applicant: Intelligent Dots, LLC. Device class: 2.

Clearance details

Applicant: Intelligent Dots, LLC
Product code: Code BZQ
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2025-09-29
Decision date: 2026-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Peachtree Corner, GA, US

Download summary PDF View on FDA.gov ↗

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