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510(k) K921002

Device
RONDEX MASK MODELS 9122/9111/9102/911102, MODIFIED
Applicant
RONDEX PRODUCTS, INC.
510(k) number
K921002
Product code
BTM  
Decision
Substantially Equivalent (SESE)
Decision date
1992-10-06
Date received
1992-02-25
Regulation
868.5915
Classification name
Ventilator, Emergency, Manual (resuscitator)
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Clearance type
Traditional
Third party reviewed
No

Other 510(k) Records For Product Code BTM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251631The BAG manual resuscitator and accessoriesLaerdal Medical AS2025-11-24
K243861butterflyBVMCompact Medical, Inc.2025-04-25
K221841EOlife®Archeon2023-03-18
K212905Sotair DeviceSafe Bvm Corporation2022-08-18
K210288Disposable Manual ResuscitatorXiamen Compower Medical Tech. Co., Ltd.2021-08-26
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.2018-12-07
K170663Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable ManometerForemount Enterprise Co., Ltd.2018-05-11
K152931Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant ResuscitatorAmbu A/S2016-08-29
K132172NEONATALIE RESUSCITATORLaerdal Medical A/S2015-01-15
K112852BABI PLUS NEONATAL RESUSCITATION BAGA Plus Medical2012-01-13
K102824AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRICAmbu A/S2011-01-28
K102649NEOPOP INFANT RESUSCITATOR WITH FLOW METERNeoforce Group, Inc.2011-01-06
K094003REVIVATORHersill, S.L.2010-09-17
K093081POCKET BVMMicrobvm Systems , Ltd.2010-02-05
K082092DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVEGalemed Corp.2008-10-15

Legacy Summary#

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FDA Review#

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