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510(k) K100315

12 LEAD GLOVE by I Needmd, Inc. — Product Code DRX

K100315 is an FDA 510(k) premarket notification submitted by I Needmd, Inc. for the device "12 LEAD GLOVE". The FDA issued a decision of Substantially Equivalent on April 23, 2010. The device falls under product code DRX (Electrode, Electrocardiograph), a Class II device regulated under 21 CFR 870.2360.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2010
Date Received
February 4, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Electrocardiograph
Device Class
Class II
Regulation Number
870.2360
Review Panel
CV
Submission Type

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  • K100129 — AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X (June 11, 2010)
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  • K092744 — NEONATAL ECG ELECTRODE, M203KEN (December 10, 2009)
  • K092389 — DISPOSAL ECG ELECTRODES, MODEL EASYRODE (October 13, 2009)
  • K090496 — QWIKLEAD REUSABLE ELECTROCARDIOGRAPH ELECTRODE PATCH (September 1, 2009)

FDA data resources