GALAXY SYSTEM; JUPITER— 510(k) K111055

Name: FDA 510(k) clearance K111055
Creator: U.S. Food and Drug Administration
Published: 2011-12-21

Substantially Equivalent

Personal Health Institute International

FDA 510(k) clearance K111055 for GALAXY SYSTEM; JUPITER, Substantially Equivalent on 2011-12-21. Applicant: Personal Health Institute International. Device class: 2.

Clearance details

Applicant: Personal Health Institute International
Product code: Code OLV
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2011-04-15
Decision date: 2011-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Battle Creek, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OLV

view all

K261747 — Report Studio2026-08-25
K260585 — Noxturnal Web2026-03-20
K242447 — Falcon HST2025-02-20
K241288 — Noxturnal Web2024-12-23
K240700 — HomeSleepTest (HST, HST REM+)2024-12-08

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