NATUS SLEEPWORKS, MODEL 104017— 510(k) K090277

Name: FDA 510(k) clearance K090277
Creator: U.S. Food and Drug Administration
Published: 2011-04-19

Substantially Equivalent

Excel-Tech Ltd. (Xltek)

FDA 510(k) clearance K090277 for NATUS SLEEPWORKS, MODEL 104017, Substantially Equivalent on 2011-04-19. Applicant: Excel-Tech Ltd. (Xltek). Device class: 2.

Clearance details

Applicant: Excel-Tech Ltd. (Xltek)
Product code: Code OLZ
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2009-02-04
Decision date: 2011-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakville, CA

Download summary PDF View on FDA.gov ↗

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Recalls naming K090277

K-number listed on FDA's recall record

Z-0661-2022 — IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks softwareClass II·Terminated·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·20211202

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090277.

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