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510(k) K212905

Sotair Device by Safe Bvm Corporation — Product Code BTM

K212905 is an FDA 510(k) premarket notification submitted by Safe Bvm Corporation for the device "Sotair Device". The FDA issued a decision of Substantially Equivalent on August 18, 2022. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2022
Date Received
September 13, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Manual (Resuscitator)
Device Class
Class II
Regulation Number
868.5915
Review Panel
AN
Submission Type

Other clearances for product code BTM

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  • K243861 — butterflyBVM (April 25, 2025)
  • K221841 — EOlife® (March 18, 2023)
  • K210288 — Disposable Manual Resuscitator (August 26, 2021)
  • K181583 — Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resu (December 7, 2018)
  • K170663 — Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremoun (May 11, 2018)
  • K152931 — Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR (August 29, 2016)
  • K132172 — NEONATALIE RESUSCITATOR (January 15, 2015)
  • K112852 — BABI PLUS NEONATAL RESUSCITATION BAG (January 13, 2012)
  • K102824 — AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC (January 28, 2011)

FDA data resources