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FDA 510(k)

STAR Apollo Mapping System

K-Number: K220786 · 2022-12-01

ApplicantRhythm Al, Ltd.
Decision Date2022-12-01
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STAR Apollo Mapping System is the device name listed in this FDA 510(k) record. The listed applicant is Rhythm Al, Ltd.. It received FDA 510(k) clearance on 2022-12-01 under 510(k) number K220786. 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 STAR Apollo Mapping System?

STAR Apollo Mapping System is a medical device that received FDA 510(k) clearance on 2022-12-01. The listed applicant is Rhythm Al, Ltd.. The 510(k) number is K220786.

When did STAR Apollo Mapping System receive FDA 510(k) clearance?

STAR Apollo Mapping System received FDA 510(k) clearance on 2022-12-01, under 510(k) number K220786.

Who is the listed applicant for STAR Apollo Mapping System?

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

What is the FDA product code for STAR Apollo Mapping System?

The FDA product code for STAR Apollo Mapping System is DQK.

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

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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