Last synced on 12 July 2024 at 11:04 pm

SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180098
510(k) Type
Traditional
Applicant
Maquet Critical Care AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
3/19/2019
Days to Decision
427 days
Submission Type
Summary

SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180098
510(k) Type
Traditional
Applicant
Maquet Critical Care AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
3/19/2019
Days to Decision
427 days
Submission Type
Summary