Digital Manometer (DM 50)
FDA 510(k) K901998 · Medical Support Products, Inc.
510(k) numberK901998
Submission
- Device name
- Digital Manometer (DM 50)
- Applicant
- Medical Support Products, Inc.
Lancaster, PA, US - Received
- May 2, 1990
- Decision date
- July 25, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K032593 | Mercury Medical Negative Inspiratory Force (Nif) Disposable MonometerBXR · Traditional | Mercury Medical | 02/03/2004SE |
| K912946 | Collins Digital Pulmonary ManometerBXR · Traditional | Warren E. Collins, Inc. | 01/15/1992SE |
| K904917 | Thayer Mip AdapterBXR · Traditional | Thayer Medical Corp. | 01/28/1991SE |
| K873498 | Inspiratory Force Mont Kit/Manifold/Meter/TubingBXR · Traditional | Dhd Medical Products Div. Diemolding Corp. | 03/09/1988SE |
Questions and answers
When was Digital Manometer (DM 50) cleared by the FDA?
Digital Manometer (DM 50) (K901998) received a 510(k) decision of Substantially Equivalent on July 25, 1990, 84 days after the submission was received.
What is the product code of K901998?
The FDA product code is BXR – Meter, Airway Pressure (Inspiratory Force), a Class II (moderate risk) device regulated under 21 CFR 868.1780.