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FDA 510(k)

PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602

K-Number: K002280 · 2001-02-05

ApplicantMedical Devices, Inc.
Decision Date2001-02-05
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602 is the device name listed in this FDA 510(k) record. The listed applicant is Medical Devices, Inc.. It received FDA 510(k) clearance on 2001-02-05 under 510(k) number K002280. 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 PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602?

PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602 is a medical device that received FDA 510(k) clearance on 2001-02-05. The listed applicant is Medical Devices, Inc.. The 510(k) number is K002280.

When did PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602 receive FDA 510(k) clearance?

PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602 received FDA 510(k) clearance on 2001-02-05, under 510(k) number K002280.

Who is the listed applicant for PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602?

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

What is the FDA product code for PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602?

The FDA product code for PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602 is MKJ. This falls under the Dental category.

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Other records listing Medical Devices, Inc. as applicant

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K930084MICRO-ARTHROSCOPEK943126ELECTROFLEXK940012SMARTBRACE ELECTRODEK935132HOME MICROCURRENT HMCK934619FLEXMATEK924897XENON ENDOSCOPIC ILLUMINATOR, MODEL XEI-300

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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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