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OPUS HC482 DIRECT NASAL MASK

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K063036
510(k) Type
Traditional
Applicant
FISHER & PAYKEL HEALTHCARE, LTD.
Country
New Zealand
FDA Decision
Substantially Equivalent
Decision Date
12/22/2006
Days to Decision
80 days
Submission Type
Summary

OPUS HC482 DIRECT NASAL MASK

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K063036
510(k) Type
Traditional
Applicant
FISHER & PAYKEL HEALTHCARE, LTD.
Country
New Zealand
FDA Decision
Substantially Equivalent
Decision Date
12/22/2006
Days to Decision
80 days
Submission Type
Summary