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FDA 510(k)

K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60

K-Number: K991007 · 1999-08-23

ApplicantKatecho, Inc.
Decision Date1999-08-23
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60 is the device name listed in this FDA 510(k) record. The listed applicant is Katecho, Inc.. It received FDA 510(k) clearance on 1999-08-23 under 510(k) number K991007. 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 RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60?

K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60 is a medical device that received FDA 510(k) clearance on 1999-08-23. The listed applicant is Katecho, Inc.. The 510(k) number is K991007.

When did K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60 receive FDA 510(k) clearance?

K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60 received FDA 510(k) clearance on 1999-08-23, under 510(k) number K991007.

Who is the listed applicant for K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60?

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 RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60?

The FDA product code for K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60 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.

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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.

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