Last synced on 20 May 2022 at 11:05 pm

Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181583
510(k) Type
Traditional
Applicant
Flexicare Medical Limited
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
12/7/2018
Days to Decision
175 days
Submission Type
Summary

Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181583
510(k) Type
Traditional
Applicant
Flexicare Medical Limited
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
12/7/2018
Days to Decision
175 days
Submission Type
Summary