Mercury Medical Expiratory Resistance Exerciser, Resistex
FDA 510(k) K954492 · Mercury Medical
510(k) numberK954492
Submission
- Device name
- Mercury Medical Expiratory Resistance Exerciser, Resistex
- Applicant
- Mercury Medical
Clearwater, FL, US - Received
- September 27, 1995
- Decision date
- October 21, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BWF – Spirometer, Therapeutic (Incentive)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5690
- Specialty
- Anesthesiology
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| K192000 | D R Burton OxyPAPBWF · Traditional | D R Burton Healthcare, LLC | 02/19/2020SE |
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| K183108 | Combined Aerobika OPEP and VersaPAP deviceBWF · Traditional | Trudell Medical International | 08/16/2019SE |
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More from Teleflexmedical, Inc.
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|---|---|---|
| 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 Expiratory Resistance Exerciser, Resistex cleared by the FDA?
Mercury Medical Expiratory Resistance Exerciser, Resistex (K954492) received a 510(k) decision of Substantially Equivalent on October 21, 1996, 390 days after the submission was received.
What is the product code of K954492?
The FDA product code is BWF – Spirometer, Therapeutic (Incentive), a Class II (moderate risk) device regulated under 21 CFR 868.5690.