Product code BXR— Anesthesiology
COLLINS DIGITAL PULMONARY MANOMETER
- Classification name
- Meter, Airway Pressure (Inspiratory Force)
- Device class
- Class 2
- Regulation
- 21 CFR 868.1780
- Advisory panel
- Anesthesiology
- Total cleared
- 6
- First cleared
- Most recent
Market context for product code BXR
FDA has cleared devices under product code BXR between 1988 and 2008, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2008
- 2004
- 1992
- 1991
- 1990
- 1988
Top applicants under product code BXR
Recent clearances under product code BXR
- K081693 — NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS
- K032593 — MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER
- K912946 — COLLINS DIGITAL PULMONARY MANOMETER
- K904917 — THAYER MIP ADAPTER
- K901998 — DIGITAL MANOMETER (DM 50)
- K873498 — INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBING
Data sourced from openFDA. This site is unofficial and independent of the FDA.