Manual Resuscitator

FDA 510(k) K963848 · Owens-Brigam Medical Co.

Substantially Equivalent

510(k) numberK963848

Submission

Device name
Manual Resuscitator
Applicant
Owens-Brigam Medical Co.
Newland, NC, US
Received
September 25, 1996
Decision date
July 7, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BTM – Ventilator, Emergency, Manual (Resuscitator)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5915
Specialty
Anesthesiology
Life-sustaining
Yes

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K170663Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount…BTM · Traditional Foremount Enterprise Co., Ltd.05/11/2018SE
K152931Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II…BTM · Abbreviated Ambu A/S08/29/2016SE
K132172Neonatalie ResuscitatorBTM · Abbreviated Laerdal Medical A/S01/15/2015SE
K112852Babi Plus Neonatal Resuscitation BagBTM · Traditional A Plus Medical01/13/2012SE

More from A Plus Medical

510(k)DeviceDecision
K952689Brigam Medical Disposable Anesthesia/Respiratory Face MaskBSJ · Traditional 07/11/1995SE

Questions and answers

When was Manual Resuscitator cleared by the FDA?

Manual Resuscitator (K963848) received a 510(k) decision of Substantially Equivalent on July 7, 1997, 285 days after the submission was received.

What is the product code of K963848?

The FDA product code is BTM – Ventilator, Emergency, Manual (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5915.