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FDA 510(k)

NATUS SLEEPWORKS, MODEL 104017

K-Number: K090277 · 2011-04-19

ApplicantExcel-Tech Ltd. (Xltek)
Decision Date2011-04-19
Product CodeOLZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NATUS SLEEPWORKS, MODEL 104017 is the device name listed in this FDA 510(k) record. The listed applicant is Excel-Tech Ltd. (Xltek). It received FDA 510(k) clearance on 2011-04-19 under 510(k) number K090277. The device is classified under product code OLZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NATUS SLEEPWORKS, MODEL 104017?

NATUS SLEEPWORKS, MODEL 104017 is a medical device that received FDA 510(k) clearance on 2011-04-19. The listed applicant is Excel-Tech Ltd. (Xltek). The 510(k) number is K090277.

When did NATUS SLEEPWORKS, MODEL 104017 receive FDA 510(k) clearance?

NATUS SLEEPWORKS, MODEL 104017 received FDA 510(k) clearance on 2011-04-19, under 510(k) number K090277.

Who is the listed applicant for NATUS SLEEPWORKS, MODEL 104017?

The FDA 510(k) record lists Excel-Tech Ltd. (Xltek) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NATUS SLEEPWORKS, MODEL 104017?

The FDA product code for NATUS SLEEPWORKS, MODEL 104017 is OLZ.

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Other records listing Excel-Tech Ltd. (Xltek) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K123079OLYMPIC BRAINZ MONITORK120260ICTAK100126STELLATE GRIDVIEWK081741NEUROLINK IP, MODEL PK1113

Related Devices (Code: OLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253390SOMNUM (SOMNUM)Honeynaps Co., Ltd.K253668Onera SleepMap (SLEEPMAP)Onera B.V.K250851Hypnos (369054-200)Cadwell Industries, Inc.K252330DeepRESPNox Medical EhfK250058NEAT 001Brain Electrophysiology Laboratory Company, LLCK241960DeepRESPNox Medical Ehf

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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