BXR · Meter, Airway Pressure (Inspiratory Force)
Anesthesiology · 21 CFR 868.1780 · Class 2
Overview
| Product Code | BXR |
|---|---|
| Device Name | Meter, Airway Pressure (Inspiratory Force) |
| Regulation | 21 CFR 868.1780 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
An inspiratory airway pressure meter is a device used to measure the amount of pressure produced in a patient's airway during maximal inspiration.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K081693 | NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS | Instrumentation Industries, Inc. | Sep 11, 2008 | SESE |
| K032593 | MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER | Mercury Medical | Feb 3, 2004 | SESE |
| K912946 | COLLINS DIGITAL PULMONARY MANOMETER | Warren E. Collins, Inc. | Jan 15, 1992 | SESE |
| K904917 | THAYER MIP ADAPTER | Thayer Medical Corp. | Jan 28, 1991 | SESE |
| K901998 | DIGITAL MANOMETER (DM 50) | Medical Support Products, Inc. | Jul 25, 1990 | SESE |
| K873498 | INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBING | Dhd Medical Products Div. Diemolding Corp. | Mar 9, 1988 | SESE |
Top Applicants
- Dhd Medical Products Div. Diemolding Corp. — 1 clearance
- Instrumentation Industries, Inc. — 1 clearance
- Medical Support Products, Inc. — 1 clearance
- Mercury Medical — 1 clearance
- Thayer Medical Corp. — 1 clearance
