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FDA 510(k)

TRACETS SME 5000

K-Number: K912450 · 1991-08-28

ApplicantLectec Corp.
Decision Date1991-08-28
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRACETS SME 5000 is the device name listed in this FDA 510(k) record. The listed applicant is Lectec Corp.. It received FDA 510(k) clearance on 1991-08-28 under 510(k) number K912450. 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 TRACETS SME 5000?

TRACETS SME 5000 is a medical device that received FDA 510(k) clearance on 1991-08-28. The listed applicant is Lectec Corp.. The 510(k) number is K912450.

When did TRACETS SME 5000 receive FDA 510(k) clearance?

TRACETS SME 5000 received FDA 510(k) clearance on 1991-08-28, under 510(k) number K912450.

Who is the listed applicant for TRACETS SME 5000?

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

What is the FDA product code for TRACETS SME 5000?

The FDA product code for TRACETS SME 5000 is DRX.

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Other records listing Lectec Corp. 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.

K950943ULTRA EASEK925384ISOPORE(TM) TAPE, MODIFICATIONK930258TRACET T-6000K923558ECG ELECTRODEK922959ISOPORE TAPEK904512TRACET AG 4000

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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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