Meter, Airway Pressure (Inspiratory Force)
The Meter, Airway Pressure (Inspiratory Force) is a device used to measure maximum inspiratory pressure or negative inspiratory force, providing a clinical assessment of a patient's respiratory muscle strength and readiness for ventilator weaning. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BXR, regulated under 21 CFR 868.1780 in the Anesthesiology specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- BXR
- Device Class
- FDA class 2
- Regulation Number
- 868.1780
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K081693 | NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS | Sep 11, 2008 | Substantially Equivalent | Instrumentation Industries, Inc. |
| K032593 | MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER | Feb 03, 2004 | Substantially Equivalent | Mercury Medical |
| K912946 | COLLINS DIGITAL PULMONARY MANOMETER | Jan 15, 1992 | Substantially Equivalent | Warren E. Collins, Inc. |
| K904917 | THAYER MIP ADAPTER | Jan 28, 1991 | Substantially Equivalent | Thayer Medical Corp. |
| K901998 | DIGITAL MANOMETER (DM 50) | Jul 25, 1990 | Substantially Equivalent | Medical Support Products, Inc. |
| K873498 | INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBING | Mar 09, 1988 | Substantially Equivalent | Dhd Medical Products Div. Diemolding Corp. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.