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FDA 510(k)

K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85

K-Number: K012404 · 2001-10-12

ApplicantKatecho, Inc.
Decision Date2001-10-12
Product CodeDRO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 is the device name listed in this FDA 510(k) record. The listed applicant is Katecho, Inc.. It received FDA 510(k) clearance on 2001-10-12 under 510(k) number K012404. The device is classified under product code DRO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85?

K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 is a medical device that received FDA 510(k) clearance on 2001-10-12. The listed applicant is Katecho, Inc.. The 510(k) number is K012404.

When did K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 receive FDA 510(k) clearance?

K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 received FDA 510(k) clearance on 2001-10-12, under 510(k) number K012404.

Who is the listed applicant for K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85?

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 ADULT ELECTRODE, MODEL KDP-85?

The FDA product code for K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 is DRO.

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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.

K010543KM-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-80K991007K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60

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Related Devices (Code: DRO)

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.

K012218LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODESThe Ludlow Company LPK000660ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413Medical Data ElectronicsK983196PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)Tz Medical, Inc.K983232PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERTTz Medical, Inc.K974034PORTABLE INTENSIVE CARE UNITMedical Research Laboratories, Inc.K962547CARDIOSERV PMarquette Electronics, Inc.

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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