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FDA 510(k)

I-PAD

K-Number: K062970 · 2008-01-22

ApplicantCu Medical Systems, Inc.
Decision Date2008-01-22
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

I-PAD is the device name listed in this FDA 510(k) record. The listed applicant is Cu Medical Systems, Inc.. It received FDA 510(k) clearance on 2008-01-22 under 510(k) number K062970. 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 I-PAD?

I-PAD is a medical device that received FDA 510(k) clearance on 2008-01-22. The listed applicant is Cu Medical Systems, Inc.. The 510(k) number is K062970.

When did I-PAD receive FDA 510(k) clearance?

I-PAD received FDA 510(k) clearance on 2008-01-22, under 510(k) number K062970.

Who is the listed applicant for I-PAD?

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

What is the FDA product code for I-PAD?

The FDA product code for I-PAD is MKJ. This falls under the Dental category.

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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