BXX — Calibrator, Pressure, Gas Class I
FDA product code BXX covers "Calibrator, Pressure, Gas", a Class I medical device regulated under 21 CFR 868.2620. Submissions are reviewed by the Anesthesiology panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- BXX
- Device Class
- Class I
- Regulation Number
- 868.2620
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K923397 | escalon medical trek | SINGLE DOSE GAS INJECTOR | September 14, 1992 |
| K875075 | timeter instrument | RT-200 COMPUTER INTERFACE | April 21, 1988 |
| K850029 | utah medical products | UTAH PRESSURE TRANSDUCER CALIBRATOR TRU-CAL | April 29, 1985 |
| K822746 | timeter instrument | RT-200 CALIBRATION ANALYZER | October 13, 1982 |
| K801258 | kleen test products | NEEDLE COUNTER-SURE COUNT/10 COUNT | June 4, 1980 |
| K801257 | kleen test products | NEEDLE COUNTER-SURE COUNT/30 CT. MAGN. | June 4, 1980 |
| K801256 | kleen test products | NEEDLE COUNTER-SURE COUNT-DISPOSA-TRAY | June 4, 1980 |
| K791294 | equilibrated bio systems | SPIROCAL | August 16, 1979 |
| K780981 | pennwalt | PORTABLE PNEUMATIC CALIBRATOR 65-150 | August 2, 1978 |
| K780838 | micro tronics | PERCI | July 17, 1978 |