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FDA 510(k)

COMPUMEDICS SOMTE SYSTEM

K-Number: K021176 · 2003-01-21

ApplicantCompumedics Limited
Decision Date2003-01-21
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

COMPUMEDICS SOMTE 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 2003-01-21 under 510(k) number K021176. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPUMEDICS SOMTE SYSTEM?

COMPUMEDICS SOMTE SYSTEM is a medical device that received FDA 510(k) clearance on 2003-01-21. The listed applicant is Compumedics Limited. The 510(k) number is K021176.

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

COMPUMEDICS SOMTE SYSTEM received FDA 510(k) clearance on 2003-01-21, under 510(k) number K021176.

Who is the listed applicant for COMPUMEDICS SOMTE 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 SOMTE SYSTEM?

The FDA product code for COMPUMEDICS SOMTE SYSTEM is MNR.

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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: MNR)

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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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