FDA 510(k)

MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR LAERDAL

K-Number: K955923 · 1996-10-24

Decision Date1996-10-24

Product CodeMKJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR LAERDAL 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 1996-10-24 under 510(k) number K955923. The device is classified under product code MKJ. It was reviewed by the CV advisory panel. Product code MKJ falls under the category of Dental, which includes dental instruments, materials, and equipment. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR LAERDAL?

MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR LAERDAL is a medical device that received FDA 510(k) clearance on 1996-10-24. The listed applicant is Graphic Controls Corp.. The 510(k) number is K955923.

When did MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR LAERDAL receive FDA 510(k) clearance?

MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR LAERDAL received FDA 510(k) clearance on 1996-10-24, under 510(k) number K955923.

Who is the listed applicant for MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR LAERDAL?

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 COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR LAERDAL?

The FDA product code for MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR LAERDAL is MKJ. This falls under the Dental category.

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Other records listing Graphic Controls Corp. as applicant

K981964MEDI-TRACE 4103 NEONATAL ELECTRODE K983287MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE K974730SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC)K980857MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE K972970MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE K964387POINT OF USE II SHARPS-A-GATOR

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Related Devices (Code: MKJ)

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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.