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FDA 510(k)

K-DEFIB/PACE PEDIATRIC ELECTRODE

K-Number: K934692 · 1995-01-24

ApplicantKatecho, Inc.
Decision Date1995-01-24
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

K-DEFIB/PACE PEDIATRIC ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Katecho, Inc.. It received FDA 510(k) clearance on 1995-01-24 under 510(k) number K934692. 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 K-DEFIB/PACE PEDIATRIC ELECTRODE?

K-DEFIB/PACE PEDIATRIC ELECTRODE is a medical device that received FDA 510(k) clearance on 1995-01-24. The listed applicant is Katecho, Inc.. The 510(k) number is K934692.

When did K-DEFIB/PACE PEDIATRIC ELECTRODE receive FDA 510(k) clearance?

K-DEFIB/PACE PEDIATRIC ELECTRODE received FDA 510(k) clearance on 1995-01-24, under 510(k) number K934692.

Who is the listed applicant for K-DEFIB/PACE PEDIATRIC ELECTRODE?

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

What is the FDA product code for K-DEFIB/PACE PEDIATRIC ELECTRODE?

The FDA product code for K-DEFIB/PACE PEDIATRIC ELECTRODE is MKJ. This falls under the Dental category.

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Other records listing Katecho, 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.

K012404K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85K010543KM-30 TENS ELECTRODEK003228K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70AK002806K-DEFIB/PACE, MODEL KDP-60AK000870KM-10 TENS ELECTRODEK993745K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80

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Related Devices (Code: MKJ)

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.

K131550HEART SYNCHeart Sync, Inc.K130684PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATORPhilips Medical SystemsK131494HEART SYNCHeart Sync, Inc.K130454LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITORPhysio-Control, Inc.K123881HEARTSINE SAMARITAN PAD 350PHeartsine Technologies, Inc.K130153HEARSTART MRX WITH AIRWAY CONFIMRATION ASSISTPhilips Medical Systems

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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