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FDA 510(k)

MEDI-TRACE 4103 NEONATAL ELECTRODE

K-Number: K981964 · 1998-11-13

ApplicantGraphic Controls Corp.
Decision Date1998-11-13
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDI-TRACE 4103 NEONATAL ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Graphic Controls Corp.. It received FDA 510(k) clearance on 1998-11-13 under 510(k) number K981964. 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 MEDI-TRACE 4103 NEONATAL ELECTRODE?

MEDI-TRACE 4103 NEONATAL ELECTRODE is a medical device that received FDA 510(k) clearance on 1998-11-13. The listed applicant is Graphic Controls Corp.. The 510(k) number is K981964.

When did MEDI-TRACE 4103 NEONATAL ELECTRODE receive FDA 510(k) clearance?

MEDI-TRACE 4103 NEONATAL ELECTRODE received FDA 510(k) clearance on 1998-11-13, under 510(k) number K981964.

Who is the listed applicant for MEDI-TRACE 4103 NEONATAL ELECTRODE?

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

What is the FDA product code for MEDI-TRACE 4103 NEONATAL ELECTRODE?

The FDA product code for MEDI-TRACE 4103 NEONATAL ELECTRODE is DRX.

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Other records listing Graphic Controls 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.

K983287MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODEK974730SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC)K980857MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODEK972970MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODEK964387POINT OF USE II SHARPS-A-GATORK964279SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)

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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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