510(k) K181583— 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 40CMH20

Substantially Equivalent

Flexicare Medical Limited.

Clearance details

Applicant: Flexicare Medical Limited.
Product code: Code BTM
Advisory panel: Anesthesiology
Date received: 2018-06-15
Decision date: 2018-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain Ash, GB

Adverse events under product code BTM

product code BTM

Death: 19
Other: 2
Total: 21

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.