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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K102454
510(k) Type
Traditional
Applicant
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/25/2011
Days to Decision
424 days
Submission Type
Summary

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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K102454
510(k) Type
Traditional
Applicant
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/25/2011
Days to Decision
424 days
Submission Type
Summary