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FDA 510(k)

L30-LB- INFANT LIMB BAND

K-Number: K893245 · 1989-06-20

ApplicantContour Electrodes, Inc.
Decision Date1989-06-20
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

L30-LB- INFANT LIMB BAND is the device name listed in this FDA 510(k) record. The listed applicant is Contour Electrodes, Inc.. It received FDA 510(k) clearance on 1989-06-20 under 510(k) number K893245. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the L30-LB- INFANT LIMB BAND?

L30-LB- INFANT LIMB BAND is a medical device that received FDA 510(k) clearance on 1989-06-20. The listed applicant is Contour Electrodes, Inc.. The 510(k) number is K893245.

When did L30-LB- INFANT LIMB BAND receive FDA 510(k) clearance?

L30-LB- INFANT LIMB BAND received FDA 510(k) clearance on 1989-06-20, under 510(k) number K893245.

Who is the listed applicant for L30-LB- INFANT LIMB BAND?

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

What is the FDA product code for L30-LB- INFANT LIMB BAND?

The FDA product code for L30-LB- INFANT LIMB BAND is DRX.

Related Clinical Trials

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Other records listing Contour Electrodes, 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.

K900682PHANTOM RADIOTRANSLUCENT ECG MONITORING ELECTRODEK881085SOFT-E SERIES T-10 ACCUTRACE TAB RESTING ELECTRODEK871412CONTOUR SOFT-E SERIES CONDUCTIVE SOLID GEL ELECTRO

Related Devices (Code: DRX)

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.

K171244PhysiotraceNimbleheart, Inc.K123658BIOMODULE 3-M1Zephyr Technology CorporationK101576CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODESTeam Innovations, Inc.K101685IP-SETIntegral Process SasK100129AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO XAmbu A/SK093327INTCO TAB ELECTRODEShanghai Intco Electrode Manufacturing 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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