Product code BXR
- Device name
- Meter, Airway Pressure (Inspiratory Force)
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.1780
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K081693 | NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS | Instrumentation Industries, Inc. | 2008-09-11 |
| K032593 | MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER | Mercury Medical | 2004-02-03 |
| K912946 | COLLINS DIGITAL PULMONARY MANOMETER | Warren E. Collins, Inc. | 1992-01-15 |
| K904917 | THAYER MIP ADAPTER | Thayer Medical Corp. | 1991-01-28 |
| K901998 | DIGITAL MANOMETER (DM 50) | Medical Support Products, Inc. | 1990-07-25 |
| K873498 | INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBING | Dhd Medical Products Div. Diemolding Corp. | 1988-03-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10788942560659 | Portex | ICU MEDICAL, INC. | 2016-10-11 |
| 10788942560604 | Portex | ICU MEDICAL, INC. | 2016-10-11 |
| 10788942548008 | Portex | ICU MEDICAL, INC. | 2016-10-11 |
| 10788942547001 | Portex | ICU MEDICAL, INC. | 2016-10-11 |
| 00260720011285 | Allied Healthcare Products Inc. | ALLIED HEALTHCARE PRODUCTS, INC. | 2016-09-16 |
| 00026072011287 | Allied Medical LLC | Allied Medical, LLC | 2016-09-16 |
| M996NSGC0 | NS-GC Gauge Cover | INSTRUMENTATION INDUSTRIES, INCORPORATED | 2016-07-29 |
| M996NSGS0 | NS-GS Gauge Stand | INSTRUMENTATION INDUSTRIES, INCORPORATED | 2016-07-29 |
| M996NS60TRR0 | NS 60-TRR Negative Inspiratory Force (NIF) Meter | INSTRUMENTATION INDUSTRIES, INCORPORATED | 2016-07-29 |
| M996NS60TBR0 | NS 60-TBR Negative Inspiratory Force (NIF) Meter | INSTRUMENTATION INDUSTRIES, INCORPORATED | 2016-07-29 |
| M996NS60PBR0 | NS 60-PBR Negative Inspiratory Force (NIF) Meter | INSTRUMENTATION INDUSTRIES, INCORPORATED | 2016-07-29 |
| M996NS30TRR0 | NS 30-TRR Negative Inspiratory Force (NIF) Meter | INSTRUMENTATION INDUSTRIES, INCORPORATED | 2016-07-29 |
| M996NS30PBR0 | NS 30-PBR Negative Inspiratory Force (NIF) Meter | INSTRUMENTATION INDUSTRIES, INCORPORATED | 2016-07-29 |
| M996NS120TRR0 | NS 120-TRR Negative Inspiratory Force (NIF) Meter | INSTRUMENTATION INDUSTRIES, INCORPORATED | 2016-07-29 |
| M996BE14910 | BE 149-1 Gauge Adapter | INSTRUMENTATION INDUSTRIES, INCORPORATED | 2016-07-29 |
| M996BE14860 | BE 148-6 Gauge Adapter | INSTRUMENTATION INDUSTRIES, INCORPORATED | 2016-07-29 |
| M996BE14810 | BE 148-1 Gauge Adapter | INSTRUMENTATION INDUSTRIES, INCORPORATED | 2016-07-29 |
| 10641043340004 | NIFometer | MERCURY ENTERPRISES, INC. | 2016-04-01 |
| 30641043340008 | NIFometer | MERCURY ENTERPRISES, INC. | 2016-04-01 |
| 10641043340011 | NIFometer | MERCURY ENTERPRISES, INC. | 2016-04-01 |
| 30641043340022 | NIFometer | MERCURY ENTERPRISES, INC. | 2016-04-01 |
| 30641043340039 | NIFometer | MERCURY ENTERPRISES, INC. | 2016-04-01 |
| 10641043340035 | NIFometer | MERCURY ENTERPRISES, INC. | 2016-04-01 |
| 10641043340028 | NIFometer | MERCURY ENTERPRISES, INC. | 2016-04-01 |