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Capnostream 35 Portable Respiratory Monitor

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200594
510(k) Type
Traditional
Applicant
Oridion Medical 1987 Ltd.
Country
Israel
FDA Decision
Substantially Equivalent
Decision Date
4/27/2020
Days to Decision
52 days
Submission Type
Summary

Capnostream 35 Portable Respiratory Monitor

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200594
510(k) Type
Traditional
Applicant
Oridion Medical 1987 Ltd.
Country
Israel
FDA Decision
Substantially Equivalent
Decision Date
4/27/2020
Days to Decision
52 days
Submission Type
Summary