Product code BXX— Anesthesiology
NEEDLE COUNTER-SURE COUNT-DISPOSA-TRAY
- Classification name
- Calibrator, Pressure, Gas
- Device class
- Class 1
- Regulation
- 21 CFR 868.2620
- Advisory panel
- Anesthesiology
- Total cleared
- 10
- First cleared
- Most recent
Market context for product code BXX
FDA has cleared devices under product code BXX between 1978 and 1992, filed by 7 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1992
- 1988
- 1985
- 1982
- 1980
- 1979
- 1978
Top applicants under product code BXX
Recent clearances under product code BXX
- K923397 — SINGLE DOSE GAS INJECTOR
- K875075 — RT-200 COMPUTER INTERFACE
- K850029 — UTAH PRESSURE TRANSDUCER CALIBRATOR TRU-CAL
- K822746 — RT-200 CALIBRATION ANALYZER
- K801256 — NEEDLE COUNTER-SURE COUNT-DISPOSA-TRAY
- K801257 — NEEDLE COUNTER-SURE COUNT/30 CT. MAGN.
- K801258 — NEEDLE COUNTER-SURE COUNT/10 COUNT
- K791294 — SPIROCAL
- K780981 — PORTABLE PNEUMATIC CALIBRATOR 65-150
- K780838 — PERCI
Data sourced from openFDA. This site is unofficial and independent of the FDA.