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FDA 510(k)

Aquilo Sports CCT1500 System

K-Number: K223164 · 2022-11-04

Decision Date2022-11-04
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Aquilo Sports CCT1500 System is the device name listed in this FDA 510(k) record. The listed applicant is Aquilo Sports, LLC. It received FDA 510(k) clearance on 2022-11-04 under 510(k) number K223164. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aquilo Sports CCT1500 System?

Aquilo Sports CCT1500 System is a medical device that received FDA 510(k) clearance on 2022-11-04. The listed applicant is Aquilo Sports, LLC. The 510(k) number is K223164.

When did Aquilo Sports CCT1500 System receive FDA 510(k) clearance?

Aquilo Sports CCT1500 System received FDA 510(k) clearance on 2022-11-04, under 510(k) number K223164.

Who is the listed applicant for Aquilo Sports CCT1500 System?

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

What is the FDA product code for Aquilo Sports CCT1500 System?

The FDA product code for Aquilo Sports CCT1500 System is IRP.

Related Clinical Trials

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.

Related Devices (Code: IRP)

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.

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.