physIQ Heart Rhythm and Respiratory Module

FDA 510(k) K183322 · Physiq, Inc.

Substantially Equivalent

510(k) numberK183322

Submission

Device name
physIQ Heart Rhythm and Respiratory Module
Applicant
Physiq, Inc.
Naperville, IL, US
Received
November 30, 2018
Decision date
July 10, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DPS – Electrocardiograph
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2340
Specialty
Cardiovascular

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More from Masimo Corporation

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K193415physIQ Heart Rhythm and Respiration ModuleDPS · Traditional 06/11/2020SE
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Questions and answers

When was physIQ Heart Rhythm and Respiratory Module cleared by the FDA?

physIQ Heart Rhythm and Respiratory Module (K183322) received a 510(k) decision of Substantially Equivalent on July 10, 2019, 222 days after the submission was received.

What is the product code of K183322?

The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.