BXX · Calibrator, Pressure, Gas
Anesthesiology · 21 CFR 868.2620 · Class 1
Overview
| Product Code | BXX |
|---|---|
| Device Name | Calibrator, Pressure, Gas |
| Regulation | 21 CFR 868.2620 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
A gas pressure calibrator is a device intended for medical purposes that is used to calibrate pressure-measuring instruments by generating a known gas pressure.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Recent Cleared Devices (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K923397 | SINGLE DOSE GAS INJECTOR | Escalon Medical Trek | Sep 14, 1992 | SESE |
| K875075 | RT-200 COMPUTER INTERFACE | Timeter Instrument Corp. | Apr 21, 1988 | SESE |
| K850029 | UTAH PRESSURE TRANSDUCER CALIBRATOR TRU-CAL | Utah Medical Products, Inc. | Apr 29, 1985 | SESE |
| K822746 | RT-200 CALIBRATION ANALYZER | Timeter Instrument Corp. | Oct 13, 1982 | SESE |
| K801258 | NEEDLE COUNTER-SURE COUNT/10 COUNT | Kleen Test Products | Jun 4, 1980 | SESE |
| K801257 | NEEDLE COUNTER-SURE COUNT/30 CT. MAGN. | Kleen Test Products | Jun 4, 1980 | SESE |
| K801256 | NEEDLE COUNTER-SURE COUNT-DISPOSA-TRAY | Kleen Test Products | Jun 4, 1980 | SESE |
| K791294 | SPIROCAL | Equilibrated Bio Systems, Inc. | Aug 16, 1979 | SESE |
| K780981 | PORTABLE PNEUMATIC CALIBRATOR 65-150 | Pennwalt Corp. | Aug 2, 1978 | SESE |
| K780838 | PERCI | Micro Tronics Corp. | Jul 17, 1978 | SESE |
Top Applicants
- Kleen Test Products — 3 clearances
- Timeter Instrument Corp. — 2 clearances
- Equilibrated Bio Systems, Inc. — 1 clearance
- Escalon Medical Trek — 1 clearance
- Micro Tronics Corp. — 1 clearance
