Product code BXK
- Device name
- Gas, Calibration (Specified Concentration)
- Medical specialty
- Anesthesiology
- Device class
- 1
- Regulation number
- 868.6400
- 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 |
|---|---|---|---|
| K954804 | LUNG DIFFUSION MIXTURES | Mittler Supply, Inc. | 1996-01-25 |
| K954803 | BLOOD GAS MIXTURES | Mittler Supply, Inc. | 1996-01-25 |
| K954542 | LUNG DIFFUSION MIXTURE | Liquid Technology Corp. | 1995-12-22 |
| K952838 | MEDICAL MIXTURE-LUNG DIFFUSION GAS MIXTURES | Standard Welders Supply Co. | 1995-09-19 |
| K953934 | MED-TECH LUNG DIFFUSION MIXTURE | Medical Technical Gases Inc.. | 1995-09-18 |
| K953208 | MEDICAL MIXTURE-CLINICAL BLOOD GAS MIXTURES | Standard Welders Supply Co. | 1995-07-20 |
| K944998 | CALIBRATION GAS | Sunox, Inc. | 1995-02-03 |
| K944812 | CLINICAL BLOOD GAS MIXTURE | Laboratory & Specialty Gases, Inc. | 1995-02-01 |
| K942866 | CLINICAL BLOOD GAS MIXTURE | Nordan Smith Welding Supplies | 1994-09-01 |
| K932874 | BLOOD GAS MIXTURE | Tri-Gas, Inc. | 1994-01-27 |
| K935311 | CLINICAL BLOOD GAS | Acetylene Gas Co. | 1993-12-22 |
| K932520 | CALIBRATION GAS | Cryodyne Technologies, Inc. | 1993-08-19 |
| K924796 | LUNG DIFFUSION GAS MIXTURE | Gulf States Airgas | 1992-12-17 |
| K924795 | BLOOD GAS MIXTURE | Gulf States Airgas | 1992-12-17 |
| K911264 | CALIBRATION KIT | S & W Medico Teknik | 1991-08-02 |
| K911471 | LUNG DIFFUSION GAS MIXTURES | Norco, Inc. | 1991-06-18 |
| K902754 | ANESTHETIC GAS CALIBRATION MIXTURE | Liquid Air Corp. | 1990-12-19 |
| K882210 | MEDIBLEND (TM) LUNG DIFFUSION GAS MIXTURES | Linde Div. Union Carbide Corp. | 1988-06-21 |
| K873586 | LUNG DIFFUSION GAS | National Welders | 1988-02-12 |
| K874297 | CALIBRATION GAS FOR CARBON DIOXIDE MONITOR | Liquid Air Corp. | 1987-12-21 |
| K873587 | BLOOD ANALYSIS GAS | National Welders | 1987-10-30 |
| K871100 | O.1 TO 25.0% CARB. DIOX. U.S.P. BALANCE OXYGEN USP | Matheson Gas Products, Inc. | 1987-04-21 |
| K871103 | O.1 T0 40.0% CARBON DIOX. O.1 TO 90.0% OXY. U.S.P | Matheson Gas Products, Inc. | 1987-04-20 |
| K871102 | O.1 TO 50.0% CARBON DIOXIDE, USP BALANCE NITRO.,NF | Matheson Gas Products, Inc. | 1987-04-20 |
| K871101 | 0.1 TO 25.0% OXYGEN, USP, BALANCE NITROGEN, N.F. | Matheson Gas Products, Inc. | 1987-04-20 |
| K870139 | GAS, CALIBRATION, SPECIFIED CONCENTRATION | Portland Welding Supply, Inc. | 1987-02-10 |
| K863675 | CALIBRATION GAS FOR SERVO GAS MONITOR 120 | Siemens Elema AB | 1986-11-03 |
| K822753 | BLOOD GAS MIXTURE | Liquid Carbonic Corp. | 1982-10-22 |
| K822762 | CLINICAL GAS MIXTURE-FLAMMABLE | Liquid Carbonic Corp. | 1982-10-22 |
| K822763 | CLINICAL GAS MIXTURE-NON-FLAMMABLE | Liquid Carbonic Corp. | 1982-10-22 |
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| 00819601021914 | Scott Medical Products | AIRGAS USA LLC | 2020-05-22 |
| 00819601021655 | Scott Medical Products | AIRGAS USA LLC | 2020-03-25 |