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FDA 510(k)

AIR Anterior Array, AIR Posterior Array

K-Number: K172695 · 2017-11-22

ApplicantGe Healthcare Coils (Usa Instruments, Inc.)
Decision Date2017-11-22
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AIR Anterior Array, AIR Posterior Array is a medical device manufactured by Ge Healthcare Coils (Usa Instruments, Inc.). It received FDA 510(k) clearance on 2017-11-22 under approval number K172695. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIR Anterior Array, AIR Posterior Array?

AIR Anterior Array, AIR Posterior Array is a medical device that received FDA 510(k) clearance on 2017-11-22. It is manufactured by Ge Healthcare Coils (Usa Instruments, Inc.). The 510(k) number is K172695.

When was AIR Anterior Array, AIR Posterior Array approved by the FDA?

AIR Anterior Array, AIR Posterior Array received FDA 510(k) clearance on 2017-11-22, under approval number K172695.

What company makes AIR Anterior Array, AIR Posterior Array?

AIR Anterior Array, AIR Posterior Array is manufactured by Ge Healthcare Coils (Usa Instruments, Inc.).

What is the FDA product code for AIR Anterior Array, AIR Posterior Array?

The FDA product code for AIR Anterior Array, AIR Posterior Array is MOS.

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Other Devices by Ge Healthcare Coils (Usa Instruments, Inc.)

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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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