Biomodule 3-M1

FDA 510(k) K123658 · Zephyr Technology Corporation

Substantially Equivalent

510(k) numberK123658

Submission

Device name
Biomodule 3-M1
Applicant
Zephyr Technology Corporation
Stamford, CT, US
Received
November 28, 2012
Decision date
April 24, 2013
Decision
Substantially Equivalent (SESE)
Type
Traditional 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 Biomodule 3-M1 cleared by the FDA?

Biomodule 3-M1 (K123658) received a 510(k) decision of Substantially Equivalent on April 24, 2013, 147 days after the submission was received.

What is the product code of K123658?

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