Last synced on 27 January 2023 at 11:04 pm

Optiflow Oxygen Kit

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211096
510(k) Type
Traditional
Applicant
Fisher &Paykel Healthcare Ltd.
Country
New Zealand
FDA Decision
Substantially Equivalent
Decision Date
1/28/2022
Days to Decision
290 days
Submission Type
Summary

Optiflow Oxygen Kit

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211096
510(k) Type
Traditional
Applicant
Fisher &Paykel Healthcare Ltd.
Country
New Zealand
FDA Decision
Substantially Equivalent
Decision Date
1/28/2022
Days to Decision
290 days
Submission Type
Summary