Cardiobelt Electrode Belt

FDA 510(k) K063044 · Monebo Technologies, Inc.

Substantially Equivalent

510(k) numberK063044

Submission

Device name
Cardiobelt Electrode Belt
Applicant
Monebo Technologies, Inc.
Austin, TX, US
Received
October 4, 2006
Decision date
March 23, 2007
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DRX – Electrode, Electrocardiograph
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2360
Specialty
Cardiovascular

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Questions and answers

When was Cardiobelt Electrode Belt cleared by the FDA?

Cardiobelt Electrode Belt (K063044) received a 510(k) decision of Substantially Equivalent on March 23, 2007, 170 days after the submission was received.

What is the product code of K063044?

The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.