Sotair Device
K-Number: K212905 · 2022-08-18
ApplicantSafe Bvm Corporation
Decision Date2022-08-18
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Sotair Device is a medical device manufactured by Safe Bvm Corporation. It received FDA 510(k) clearance on 2022-08-18 under approval number K212905. The device is classified under product code BTM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sotair Device?
Sotair Device is a medical device that received FDA 510(k) clearance on 2022-08-18. It is manufactured by Safe Bvm Corporation. The 510(k) number is K212905.
When was Sotair Device approved by the FDA?
Sotair Device received FDA 510(k) clearance on 2022-08-18, under approval number K212905.
What company makes Sotair Device?
Sotair Device is manufactured by Safe Bvm Corporation.
What is the FDA product code for Sotair Device?
The FDA product code for Sotair Device is BTM.
Related Devices (Code: BTM)
K152931Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant ResuscitatorAmbu A/S
K181583Adult 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 40CMH20Flexicare Medical Limited.
K170663Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable ManometerForemount Enterprise Co., Ltd.
K210288Disposable Manual ResuscitatorXiamen Compower Medical Tech. Co., Ltd.
K221841EOlife®Archeon
K251631The BAG manual resuscitator and accessoriesLaerdal Medical AS
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.