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FDA 510(k)

I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM

K-Number: K102454 · 2011-10-25

ApplicantRespironics Respiratory Drug Delivery (Uk) , Ltd.
Decision Date2011-10-25
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Respironics Respiratory Drug Delivery (Uk) , Ltd.. It received FDA 510(k) clearance on 2011-10-25 under 510(k) number K102454. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM?

I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM is a medical device that received FDA 510(k) clearance on 2011-10-25. The listed applicant is Respironics Respiratory Drug Delivery (Uk) , Ltd.. The 510(k) number is K102454.

When did I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM receive FDA 510(k) clearance?

I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM received FDA 510(k) clearance on 2011-10-25, under 510(k) number K102454.

Who is the listed applicant for I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM?

The FDA 510(k) record lists Respironics Respiratory Drug Delivery (Uk) , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM?

The FDA product code for I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM is CAF.

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Other records listing Respironics Respiratory Drug Delivery (Uk) , Ltd. as applicant

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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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