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MiniBox +

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161295
510(k) Type
Traditional
Applicant
PULMONE ADVANCED MEDICAL DEVICES, LTD
Country
Israel
FDA Decision
Substantially Equivalent
Decision Date
10/21/2016
Days to Decision
165 days
Submission Type
Summary

MiniBox +

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161295
510(k) Type
Traditional
Applicant
PULMONE ADVANCED MEDICAL DEVICES, LTD
Country
Israel
FDA Decision
Substantially Equivalent
Decision Date
10/21/2016
Days to Decision
165 days
Submission Type
Summary