Braemar Cardiokey Holter Recorder

FDA 510(k) K130294 · Braemar Manufacturing, LLC

Substantially Equivalent

510(k) numberK130294

Submission

Device name
Braemar Cardiokey Holter Recorder
Applicant
Braemar Manufacturing, LLC
San Diego, CA, US
Received
February 6, 2013
Decision date
October 16, 2013
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MWJ – Electrocardiograph, Ambulatory (Without Analysis)
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2800
Specialty
Cardiovascular

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Questions and answers

When was Braemar Cardiokey Holter Recorder cleared by the FDA?

Braemar Cardiokey Holter Recorder (K130294) received a 510(k) decision of Substantially Equivalent on October 16, 2013, 252 days after the submission was received.

What is the product code of K130294?

The FDA product code is MWJ – Electrocardiograph, Ambulatory (Without Analysis), a Class II (moderate risk) device regulated under 21 CFR 870.2800.