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FDA 510(k)

physiQ Heart Rhythm Module

K-Number: K180234 · 2018-08-10

ApplicantPhysiq, Inc.
Decision Date2018-08-10
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

physiQ Heart Rhythm Module is the device name listed in this FDA 510(k) record. The listed applicant is Physiq, Inc.. It received FDA 510(k) clearance on 2018-08-10 under 510(k) number K180234. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the physiQ Heart Rhythm Module?

physiQ Heart Rhythm Module is a medical device that received FDA 510(k) clearance on 2018-08-10. The listed applicant is Physiq, Inc.. The 510(k) number is K180234.

When did physiQ Heart Rhythm Module receive FDA 510(k) clearance?

physiQ Heart Rhythm Module received FDA 510(k) clearance on 2018-08-10, under 510(k) number K180234.

Who is the listed applicant for physiQ Heart Rhythm Module?

The FDA 510(k) record lists Physiq, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for physiQ Heart Rhythm Module?

The FDA product code for physiQ Heart Rhythm Module is DPS.

Other records listing Physiq, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K193415physIQ Heart Rhythm and Respiration ModuleK183322physIQ Heart Rhythm and Respiratory Module

Related Devices (Code: DPS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France CommercialK243252ZBPro DiagnosticZbeats, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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