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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 a medical device manufactured by Rhythm Al, Ltd.. It received FDA 510(k) clearance on 2022-12-01 under approval 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. It is manufactured by Rhythm Al, Ltd.. The 510(k) number is K220786.

When was STAR Apollo Mapping System approved by the FDA?

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

What company makes STAR Apollo Mapping System?

STAR Apollo Mapping System is manufactured by Rhythm Al, Ltd..

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

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

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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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