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FDA 510(k)

Universal Pilot Guidance Instrument System

K-Number: K213491 · 2022-05-12

ApplicantCtl Medical Corporation
Decision Date2022-05-12
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Universal Pilot Guidance Instrument System is the device name listed in this FDA 510(k) record. The listed applicant is Ctl Medical Corporation. It received FDA 510(k) clearance on 2022-05-12 under 510(k) number K213491. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Universal Pilot Guidance Instrument System?

Universal Pilot Guidance Instrument System is a medical device that received FDA 510(k) clearance on 2022-05-12. The listed applicant is Ctl Medical Corporation. The 510(k) number is K213491.

When did Universal Pilot Guidance Instrument System receive FDA 510(k) clearance?

Universal Pilot Guidance Instrument System received FDA 510(k) clearance on 2022-05-12, under 510(k) number K213491.

Who is the listed applicant for Universal Pilot Guidance Instrument System?

The FDA 510(k) record lists Ctl Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Universal Pilot Guidance Instrument System?

The FDA product code for Universal Pilot Guidance Instrument System is OLO.

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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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