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FDA 510(k)

PEDIATRIC DEFIB K-PADS

K-Number: K935083 · 1994-07-25

ApplicantKatecho, Inc.
Decision Date1994-07-25
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

PEDIATRIC DEFIB K-PADS is the device name listed in this FDA 510(k) record. The listed applicant is Katecho, Inc.. It received FDA 510(k) clearance on 1994-07-25 under 510(k) number K935083. The device is classified under product code LDD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the PEDIATRIC DEFIB K-PADS?

PEDIATRIC DEFIB K-PADS is a medical device that received FDA 510(k) clearance on 1994-07-25. The listed applicant is Katecho, Inc.. The 510(k) number is K935083.

When did PEDIATRIC DEFIB K-PADS receive FDA 510(k) clearance?

PEDIATRIC DEFIB K-PADS received FDA 510(k) clearance on 1994-07-25, under 510(k) number K935083.

Who is the listed applicant for PEDIATRIC DEFIB K-PADS?

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 PEDIATRIC DEFIB K-PADS?

The FDA product code for PEDIATRIC DEFIB K-PADS is LDD.

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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: LDD)

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.

K203231Switched Internal PaddlesPhilips North America, LLCK200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips CompanyK182503Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitorsPhysio-Control, Inc.K103651CARDIOMEDCardio Medical Products, Inc.K103783EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRICFiab SpaK103334CARDIO MEDCardio Medical Products, 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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