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FDA 510(k)

SOMNO STAR & SERIES SLEEP SYSTEM

K-Number: K012085 · 2001-08-02

ApplicantSensor Medics Corp.
Decision Date2001-08-02
Product CodeOLV
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SOMNO STAR & SERIES SLEEP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sensor Medics Corp.. It received FDA 510(k) clearance on 2001-08-02 under 510(k) number K012085. The device is classified under product code OLV. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOMNO STAR & SERIES SLEEP SYSTEM?

SOMNO STAR & SERIES SLEEP SYSTEM is a medical device that received FDA 510(k) clearance on 2001-08-02. The listed applicant is Sensor Medics Corp.. The 510(k) number is K012085.

When did SOMNO STAR & SERIES SLEEP SYSTEM receive FDA 510(k) clearance?

SOMNO STAR & SERIES SLEEP SYSTEM received FDA 510(k) clearance on 2001-08-02, under 510(k) number K012085.

Who is the listed applicant for SOMNO STAR & SERIES SLEEP SYSTEM?

The FDA 510(k) record lists Sensor Medics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOMNO STAR & SERIES SLEEP SYSTEM?

The FDA product code for SOMNO STAR & SERIES SLEEP SYSTEM is OLV.

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Other records listing Sensor Medics Corp. as applicant

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Related Devices (Code: OLV)

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K261747Report StudioBeacon Biosignals, Inc.K260585Noxturnal WebNox Medical EhfK242447Falcon HSTCompumedics LimitedK241288Noxturnal WebNox Medical EhfK240700HomeSleepTest (HST, HST REM+)Somnomedics GmbHK213007Cerebra Sleep SystemCerebra Medical , Ltd.

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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