Mercury Medical Negative Inspiratory Force (Nif) Disposable Monometer
FDA 510(k) K032593 · Mercury Medical
510(k) numberK032593
Submission
- Device name
- Mercury Medical Negative Inspiratory Force (Nif) Disposable Monometer
- Applicant
- Mercury Medical
Clearwater, FL, US - Received
- August 22, 2003
- Decision date
- February 3, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BXR – Meter, Airway Pressure (Inspiratory Force)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1780
- Specialty
- Anesthesiology
Other 510(k)s with product code BXR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K081693 | NS Series Nif (Negative Inspiratory Force) MetersBXR · Traditional | Instrumentation Industries, Inc. | 09/11/2008SE |
| K912946 | Collins Digital Pulmonary ManometerBXR · Traditional | Warren E. Collins, Inc. | 01/15/1992SE |
| K904917 | Thayer Mip AdapterBXR · Traditional | Thayer Medical Corp. | 01/28/1991SE |
| K901998 | Digital Manometer (DM 50)BXR · Traditional | Medical Support Products, Inc. | 07/25/1990SE |
| K873498 | Inspiratory Force Mont Kit/Manifold/Meter/TubingBXR · Traditional | Dhd Medical Products Div. Diemolding Corp. | 03/09/1988SE |
More from Dhd Medical Products Div. Diemolding Corp.
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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 |
| 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 |
| K970756 | Mercury Medical Reusable CPR BagBTM · Traditional | 10/31/1997SE |
Questions and answers
When was Mercury Medical Negative Inspiratory Force (Nif) Disposable Monometer cleared by the FDA?
Mercury Medical Negative Inspiratory Force (Nif) Disposable Monometer (K032593) received a 510(k) decision of Substantially Equivalent on February 3, 2004, 165 days after the submission was received.
What is the product code of K032593?
The FDA product code is BXR – Meter, Airway Pressure (Inspiratory Force), a Class II (moderate risk) device regulated under 21 CFR 868.1780.