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FDA 510(k)

RhythmAnalytics

K-Number: K182344 · 2019-03-07

ApplicantBiofourmis Singapore Pte., Ltd.
Decision Date2019-03-07
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RhythmAnalytics is the device name listed in this FDA 510(k) record. The listed applicant is Biofourmis Singapore Pte., Ltd.. It received FDA 510(k) clearance on 2019-03-07 under 510(k) number K182344. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RhythmAnalytics?

RhythmAnalytics is a medical device that received FDA 510(k) clearance on 2019-03-07. The listed applicant is Biofourmis Singapore Pte., Ltd.. The 510(k) number is K182344.

When did RhythmAnalytics receive FDA 510(k) clearance?

RhythmAnalytics received FDA 510(k) clearance on 2019-03-07, under 510(k) number K182344.

Who is the listed applicant for RhythmAnalytics?

The FDA 510(k) record lists Biofourmis Singapore Pte., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RhythmAnalytics?

The FDA product code for RhythmAnalytics is DQK.

Other records listing Biofourmis Singapore Pte., Ltd. 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.

K233418Biofourmis Everion+ (G2)K213863Everion+ SystemK183282Biovitals Analytics Engine

Related Devices (Code: DQK)

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.

K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLCK253463ILR ECG Analyzer (IM007)Implicity, Inc.K261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc.K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd.

Official Source

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

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