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FDA 510(k)

BRAIN COIL, MODEL 9800GE-64

K-Number: K003097 · 2000-12-28

ApplicantMidwest Rf, LLC
Decision Date2000-12-28
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BRAIN COIL, MODEL 9800GE-64 is the device name listed in this FDA 510(k) record. The listed applicant is Midwest Rf, LLC. It received FDA 510(k) clearance on 2000-12-28 under 510(k) number K003097. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRAIN COIL, MODEL 9800GE-64?

BRAIN COIL, MODEL 9800GE-64 is a medical device that received FDA 510(k) clearance on 2000-12-28. The listed applicant is Midwest Rf, LLC. The 510(k) number is K003097.

When did BRAIN COIL, MODEL 9800GE-64 receive FDA 510(k) clearance?

BRAIN COIL, MODEL 9800GE-64 received FDA 510(k) clearance on 2000-12-28, under 510(k) number K003097.

Who is the listed applicant for BRAIN COIL, MODEL 9800GE-64?

The FDA 510(k) record lists Midwest Rf, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BRAIN COIL, MODEL 9800GE-64?

The FDA product code for BRAIN COIL, MODEL 9800GE-64 is MOS.

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Other records listing Midwest Rf, LLC 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.

K111259SV DBS VRAIN ARRAYK091496MEP-90 HAIR GROWTH STIMULATION SYSTEMK090267SV DBS BRAIN ARRAY, MODEL 1500SV-SMS64K051618SPECIAL PROCEDURES II HEAD COIL, MODEL 1400GE-64K030317MODEL 1300GE-64: PEDIATRIC POSITIONERK003386SPECIAL PROCEDURES HEAD COIL; MODEL # 1100GE-64

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Related Devices (Code: MOS)

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.

K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0TPhilips Medical Systems Nederland B.V.K262294dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0TPhilips Medical Systems Nederland B.V.K2609470.55T 12Ch Breast CoilNeocoil, LLCK252587HD 8Ch Wrist ArrayShenzhen RF Tech Co., Ltd.K252876GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive OnlyShenzhen RF Tech Co., Ltd.K260519Smart Fit TorsoCardiac 1.5TPhilips Healthcare (Suzhou) Co., 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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