Product code BXX
- Device name
- Calibrator, Pressure, Gas
- Medical specialty
- Anesthesiology
- Device class
- 1
- Regulation number
- 868.2620
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K923397 | SINGLE DOSE GAS INJECTOR | Escalon Medical Trek | 1992-09-14 |
| K875075 | RT-200 COMPUTER INTERFACE | Timeter Instrument Corp. | 1988-04-21 |
| K850029 | UTAH PRESSURE TRANSDUCER CALIBRATOR TRU-CAL | Utah Medical Products, Inc. | 1985-04-29 |
| K822746 | RT-200 CALIBRATION ANALYZER | Timeter Instrument Corp. | 1982-10-13 |
| K801256 | NEEDLE COUNTER-SURE COUNT-DISPOSA-TRAY | Kleen Test Products | 1980-06-04 |
| K801257 | NEEDLE COUNTER-SURE COUNT/30 CT. MAGN. | Kleen Test Products | 1980-06-04 |
| K801258 | NEEDLE COUNTER-SURE COUNT/10 COUNT | Kleen Test Products | 1980-06-04 |
| K791294 | SPIROCAL | Equilibrated Bio Systems, Inc. | 1979-08-16 |
| K780981 | PORTABLE PNEUMATIC CALIBRATOR 65-150 | Pennwalt Corp. | 1978-08-02 |
| K780838 | PERCI | Micro Tronics Corp. | 1978-07-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00630414467818 | Gas Pressure Regulator | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414196701 | Calibrating Gas Kit | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414112978 | Slope Gas | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414112961 | Cal Gas | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414055657 | Gas Cartridge Pack | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00385480485883 | Stat Profile | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480485845 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480492041 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480489553 | Stat Profile | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480489546 | Stat Profile | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480485944 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
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| 00385480420136 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480485876 | Stat Profile | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480485852 | Stat Profile | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480485838 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
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| 00385480485661 | Stat Profile | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480485647 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480485630 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480485623 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480485616 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480485586 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480420181 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480420174 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480420143 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480492058 | Stat Profile | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00853480006150 | Universal Gas Mixing Kit | ESCALON MEDICAL CORP. | 2016-01-15 |
| 10853480006157 | Universal Gas Mixing Kit | ESCALON MEDICAL CORP. | 2016-01-15 |