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AG 100s

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180991
510(k) Type
Traditional
Applicant
Hospitech Respiration Ltd.
Country
Israel
FDA Decision
Substantially Equivalent
Decision Date
10/12/2018
Days to Decision
179 days
Submission Type
Summary

AG 100s

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180991
510(k) Type
Traditional
Applicant
Hospitech Respiration Ltd.
Country
Israel
FDA Decision
Substantially Equivalent
Decision Date
10/12/2018
Days to Decision
179 days
Submission Type
Summary