Calibrator, Pressure, Gas
The Calibrator, Pressure, Gas is a reference instrument used to calibrate gas pressure measuring devices such as gauges and transducers used in respiratory and anesthesia equipment. It is classified as FDA Class 1, the lowest risk category, subject to general controls only with no premarket submission required. The product code is BXX, regulated under 21 CFR 868.2620 in the Anesthesiology specialty.
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Basic Information
- Product Code
- BXX
- Device Class
- FDA class 1
- Regulation Number
- 868.2620
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K923397 | SINGLE DOSE GAS INJECTOR | Sep 14, 1992 | Substantially Equivalent | Escalon Medical Trek |
| K875075 | RT-200 COMPUTER INTERFACE | Apr 21, 1988 | Substantially Equivalent | Timeter Instrument Corp. |
| K850029 | UTAH PRESSURE TRANSDUCER CALIBRATOR TRU-CAL | Apr 29, 1985 | Substantially Equivalent | Utah Medical Products, Inc. |
| K822746 | RT-200 CALIBRATION ANALYZER | Oct 13, 1982 | Substantially Equivalent | Timeter Instrument Corp. |
| K801258 | NEEDLE COUNTER-SURE COUNT/10 COUNT | Jun 04, 1980 | Substantially Equivalent | Kleen Test Products |
| K801257 | NEEDLE COUNTER-SURE COUNT/30 CT. MAGN. | Jun 04, 1980 | Substantially Equivalent | Kleen Test Products |
| K801256 | NEEDLE COUNTER-SURE COUNT-DISPOSA-TRAY | Jun 04, 1980 | Substantially Equivalent | Kleen Test Products |
| K791294 | SPIROCAL | Aug 16, 1979 | Substantially Equivalent | Equilibrated Bio Systems, Inc. |
| K780981 | PORTABLE PNEUMATIC CALIBRATOR 65-150 | Aug 02, 1978 | Substantially Equivalent | Pennwalt Corp. |
| K780838 | PERCI | Jul 17, 1978 | Substantially Equivalent | Micro Tronics Corp. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.