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BIPAP FOCUS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K053168
510(k) Type
Traditional
Applicant
RESPIRONICS (IRELAND) LIMITED
Country
Ireland
FDA Decision
Substantially Equivalent
Decision Date
1/4/2006
Days to Decision
51 days
Submission Type
Summary

BIPAP FOCUS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K053168
510(k) Type
Traditional
Applicant
RESPIRONICS (IRELAND) LIMITED
Country
Ireland
FDA Decision
Substantially Equivalent
Decision Date
1/4/2006
Days to Decision
51 days
Submission Type
Summary