Datex Engstom Manual Resuscitator

FDA 510(k) K970991 · Promedic, Inc.

Unknown

510(k) numberK970991

Submission

Device name
Datex Engstom Manual Resuscitator
Applicant
Promedic, Inc.
Mccordsville, IN, US
Received
March 19, 1997
Decision date
June 16, 1997
Decision
Unknown (SESK)
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

Other 510(k)s with product code BTM

510(k)DeviceApplicantDecision
K251631The BAG manual resuscitator and accessoriesBTM · Traditional Laerdal Medical AS11/24/2025SE
K243861butterflyBVMBTM · Traditional Compact Medical, Inc.04/25/2025SE
K221841EOlife®BTM · Traditional Archeon03/18/2023SE
K212905Sotair DeviceBTM · Traditional Safe Bvm Corporation08/18/2022SE
K210288Disposable Manual ResuscitatorBTM · Traditional Xiamen Compower Medical Tech. Co., Ltd.08/26/2021SE
K181583Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator…BTM · Traditional Flexicare Medical Limited.12/07/2018SE
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
K131889Eum 100PROOSP · Traditional 04/23/2014SE
K112318Clearpath 24OCX · Traditional 06/29/2012SE
K072756Non-Iv Adapter for Infant NG TubeKNT · Traditional 12/19/2007SESK
K060497BabyairCAF · Traditional 07/11/2006SE
K060842Revjet TurboCAF · Traditional 06/21/2006SE
K052903Pediatric Feeding TubeKNT · Traditional 11/09/2005SE
K031409Urinary CathetersGBM · Traditional 06/17/2003SE
K024190Fenestrated Infusion CatheterFRN · Traditional 03/17/2003SE
K023579Gas Sampling LinesCCK · Traditional 01/28/2003SE
K020005Infant Feeding TubesKNT · Traditional 07/16/2002SE

Questions and answers

When was Datex Engstom Manual Resuscitator cleared by the FDA?

Datex Engstom Manual Resuscitator (K970991) received a 510(k) decision of Unknown on June 16, 1997, 89 days after the submission was received.

What is the product code of K970991?

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