SOMNO STAR & SERIES SLEEP SYSTEM— 510(k) K012085

Name: FDA 510(k) clearance K012085
Creator: U.S. Food and Drug Administration
Published: 2001-08-02

Substantially Equivalent

Sensor Medics Corp.

FDA 510(k) clearance K012085 for SOMNO STAR & SERIES SLEEP SYSTEM, Substantially Equivalent on 2001-08-02. Applicant: Sensor Medics Corp.. Device class: 2.

Clearance details

Applicant: Sensor Medics Corp.
Product code: Code OLV
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2001-07-03
Decision date: 2001-08-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Yorba Linda, CA, 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

More clearances from Sensor Medics Corp.

view all

K032516 — HIOX80 AEROSOL ADAPTER2004-03-04
K031745 — INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION2004-02-13
K031883 — LYRA NASAL MASK2003-08-25
K030943 — MODIFICATION TO HIOX2003-04-22
K022192 — PEGASUS NASAL CPAP SYSTEM2003-01-24

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