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FDA 510(k)

12 LEAD GLOVE

K-Number: K100315 · 2010-04-23

ApplicantI Needmd, Inc.
Decision Date2010-04-23
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

12 LEAD GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is I Needmd, Inc.. It received FDA 510(k) clearance on 2010-04-23 under 510(k) number K100315. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 12 LEAD GLOVE?

12 LEAD GLOVE is a medical device that received FDA 510(k) clearance on 2010-04-23. The listed applicant is I Needmd, Inc.. The 510(k) number is K100315.

When did 12 LEAD GLOVE receive FDA 510(k) clearance?

12 LEAD GLOVE received FDA 510(k) clearance on 2010-04-23, under 510(k) number K100315.

Who is the listed applicant for 12 LEAD GLOVE?

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

What is the FDA product code for 12 LEAD GLOVE?

The FDA product code for 12 LEAD GLOVE is DRX.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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