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FDA 510(k)

GE STERILE DISPOSABLE EQUIPMENT COIL COVER

K-Number: K964141 · 1997-01-30

ApplicantContour Fabricators, Inc.
Decision Date1997-01-30
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GE STERILE DISPOSABLE EQUIPMENT COIL COVER is the device name listed in this FDA 510(k) record. The listed applicant is Contour Fabricators, Inc.. It received FDA 510(k) clearance on 1997-01-30 under 510(k) number K964141. 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 GE STERILE DISPOSABLE EQUIPMENT COIL COVER?

GE STERILE DISPOSABLE EQUIPMENT COIL COVER is a medical device that received FDA 510(k) clearance on 1997-01-30. The listed applicant is Contour Fabricators, Inc.. The 510(k) number is K964141.

When did GE STERILE DISPOSABLE EQUIPMENT COIL COVER receive FDA 510(k) clearance?

GE STERILE DISPOSABLE EQUIPMENT COIL COVER received FDA 510(k) clearance on 1997-01-30, under 510(k) number K964141.

Who is the listed applicant for GE STERILE DISPOSABLE EQUIPMENT COIL COVER?

The FDA 510(k) record lists Contour Fabricators, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GE STERILE DISPOSABLE EQUIPMENT COIL COVER?

The FDA product code for GE STERILE DISPOSABLE EQUIPMENT COIL COVER is MOS.

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Other records listing Contour Fabricators, Inc. 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.

K090773CFI ULTRASOUND PROBE DRAPEK970900INSTRUMENT HOLDERK971040CABLE HOLDER, SUCTION TUBE HOLDERK970185STERILE DISPOSABLE EQUIPMENT MAGNET COVERK963453CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046)K820692BANDBAG, WRAP, STERILE

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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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