BXRClass II
Meter, Airway Pressure (inspiratory Force)
Anesthesiology · 21 CFR 868.1780
MDR events5All time
Recalls0All time
Registered firms5Currently listed
510(k) clearances6All time
Recent MDR events
5 adverse event reports on file
- PORTEX PNEUPAC VENTILATOR SUPPORT GAUGEApr 27, 2023MalfunctionSmiths Medical Asd, Inc.3012307300-2023-04686
- INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBINGSep 19, 2022MalfunctionSmiths Medical Asd, Inc.3012307300-2022-19572
- PORTEXSep 19, 2022MalfunctionSmiths Medical Asd, Inc.3012307300-2022-19607
- PORTEX PRESSUREEASY CUFF PRESSURE MONITORMar 23, 2022MalfunctionSt Paul3012307300-2022-05071
- RESPIRATORY FORCE MEASURINGNov 27, 2002MalfunctionRusch Inc.2429473-2002-00213
Event type breakdown
Malfunction5
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
5 firms currently registered for this product code
510(k) clearances
6 clearances for this product code
- Instrumentation Industries, Inc.Sep 11, 2008
K081693 · NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS
- Mercury MedicalFeb 3, 2004
K032593 · MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER
- Warren E. Collins, Inc.Jan 15, 1992
K912946 · COLLINS DIGITAL PULMONARY MANOMETER
- Thayer Medical Corp.Jan 28, 1991
K904917 · THAYER MIP ADAPTER
- Medical Support Products, Inc.Jul 25, 1990
K901998 · DIGITAL MANOMETER (DM 50)
- Dhd Medical Products Div. Diemolding Corp.Mar 9, 1988
K873498 · INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBING