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FDA 510(k)

COMPUMEDICS SIESTA SYSTEM

K-Number: K003175 · 2000-12-27

ApplicantCompumedics Limited
Decision Date2000-12-27
Product CodeOLV
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

COMPUMEDICS SIESTA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Compumedics Limited. It received FDA 510(k) clearance on 2000-12-27 under 510(k) number K003175. 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 COMPUMEDICS SIESTA SYSTEM?

COMPUMEDICS SIESTA SYSTEM is a medical device that received FDA 510(k) clearance on 2000-12-27. The listed applicant is Compumedics Limited. The 510(k) number is K003175.

When did COMPUMEDICS SIESTA SYSTEM receive FDA 510(k) clearance?

COMPUMEDICS SIESTA SYSTEM received FDA 510(k) clearance on 2000-12-27, under 510(k) number K003175.

Who is the listed applicant for COMPUMEDICS SIESTA SYSTEM?

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

What is the FDA product code for COMPUMEDICS SIESTA SYSTEM?

The FDA product code for COMPUMEDICS SIESTA SYSTEM is OLV.

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Other records listing Compumedics Limited 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.

K252383Somfit DK242447Falcon HSTK231546SomfitK230073OktiK191785Orion LifeSpan MEGK093223COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG

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Related Devices (Code: OLV)

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.

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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