NS Series Nif (Negative Inspiratory Force) Meters
FDA 510(k) K081693 · Instrumentation Industries, Inc.
510(k) numberK081693
Submission
- Device name
- NS Series Nif (Negative Inspiratory Force) Meters
- Applicant
- Instrumentation Industries, Inc.
Bethel Park, PA, US - Received
- June 17, 2008
- Decision date
- September 11, 2008
- 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 |
|---|---|---|---|
| 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 |
| 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 |
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Questions and answers
When was NS Series Nif (Negative Inspiratory Force) Meters cleared by the FDA?
NS Series Nif (Negative Inspiratory Force) Meters (K081693) received a 510(k) decision of Substantially Equivalent on September 11, 2008, 86 days after the submission was received.
What is the product code of K081693?
The FDA product code is BXR – Meter, Airway Pressure (Inspiratory Force), a Class II (moderate risk) device regulated under 21 CFR 868.1780.