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FDA 510(k)

12-LEAD GLOVE

K-Number: K033559 · 2004-12-22

ApplicantIneedmd
Decision Date2004-12-22
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 Ineedmd. It received FDA 510(k) clearance on 2004-12-22 under 510(k) number K033559. 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 2004-12-22. The listed applicant is Ineedmd. The 510(k) number is K033559.

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

12-LEAD GLOVE received FDA 510(k) clearance on 2004-12-22, under 510(k) number K033559.

Who is the listed applicant for 12-LEAD GLOVE?

The FDA 510(k) record lists Ineedmd 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

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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