Mercury Medical Reusable CPR Bag
FDA 510(k) K970756 · Mercury Medical
510(k) numberK970756
Submission
- Device name
- Mercury Medical Reusable CPR Bag
- Applicant
- Mercury Medical
Clearwater, FL, US - Received
- March 3, 1997
- Decision date
- October 31, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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|---|---|---|---|
| K251631 | The BAG manual resuscitator and accessoriesBTM · Traditional | Laerdal Medical AS | 11/24/2025SE |
| K243861 | butterflyBVMBTM · Traditional | Compact Medical, Inc. | 04/25/2025SE |
| K221841 | EOlife®BTM · Traditional | Archeon | 03/18/2023SE |
| K212905 | Sotair DeviceBTM · Traditional | Safe Bvm Corporation | 08/18/2022SE |
| K210288 | Disposable Manual ResuscitatorBTM · Traditional | Xiamen Compower Medical Tech. Co., Ltd. | 08/26/2021SE |
| K181583 | Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator…BTM · Traditional | Flexicare Medical Limited. | 12/07/2018SE |
| K170663 | Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount…BTM · Traditional | Foremount Enterprise Co., Ltd. | 05/11/2018SE |
| K152931 | Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II…BTM · Abbreviated | Ambu A/S | 08/29/2016SE |
| K132172 | Neonatalie ResuscitatorBTM · Abbreviated | Laerdal Medical A/S | 01/15/2015SE |
| K112852 | Babi Plus Neonatal Resuscitation BagBTM · Traditional | A Plus Medical | 01/13/2012SE |
More from A Plus Medical
| 510(k) | Device | Decision |
|---|---|---|
| K142096 | T-Piece ResuscitatorBTL · Traditional | 10/17/2014SE |
| K093913 | Mercury Medical T-Piece ResuscitatorBTL · Traditional | 04/06/2010SE |
| K090710 | Mercury CPAPBYE · Traditional | 08/20/2009SE |
| K083056 | Neo-Stat CO2 <KgCCK · Traditional | 02/23/2009SE |
| K032593 | Mercury Medical Negative Inspiratory Force (Nif) Disposable MonometerBXR · Traditional | 02/03/2004SE |
| K031814 | STATCO2METER, Model 10-55372CCK · Traditional | 08/14/2003SE |
| K031411 | Mini STATCO2 CO2 Detector, Model 10-55371CCK · Traditional | 07/30/2003SE |
| K021576 | Mercury Medical STATCO2 End Tidal CO2 Detector, Model 10-55370CCK · Traditional | 11/04/2002SE |
| K001714 | Mercury Medical Hyperinflation Bag System, Model 83-900-0149NHK · Traditional | 11/03/2000SE |
| K000073 | Mercury Medical Disposable Radiofrequency CannulaGXI · Traditional | 03/01/2000SE |
Questions and answers
When was Mercury Medical Reusable CPR Bag cleared by the FDA?
Mercury Medical Reusable CPR Bag (K970756) received a 510(k) decision of Substantially Equivalent on October 31, 1997, 242 days after the submission was received.
What is the product code of K970756?
The FDA product code is BTM – Ventilator, Emergency, Manual (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5915.