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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 the device name listed in this FDA 510(k) record. The listed applicant is Ge Healthcare Coils (Usa Instruments, Inc.). It received FDA 510(k) clearance on 2017-11-22 under 510(k) 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. The listed applicant is Ge Healthcare Coils (Usa Instruments, Inc.). The 510(k) number is K172695.

When did AIR Anterior Array, AIR Posterior Array receive FDA 510(k) clearance?

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

Who is the listed applicant for AIR Anterior Array, AIR Posterior Array?

The FDA 510(k) record lists Ge Healthcare Coils (Usa Instruments, Inc.) as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Ge Healthcare Coils (Usa Instruments, Inc.) as applicant

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.

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Related Devices (Code: MOS)

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.

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Official Source

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