BXK · Gas, Calibration (Specified Concentration)
Anesthesiology · 21 CFR 868.6400 · Class 1
Overview
| Product Code | BXK |
|---|---|
| Device Name | Gas, Calibration (Specified Concentration) |
| Regulation | 21 CFR 868.6400 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
A calibration gas is a device consisting of a container of gas of known concentration intended to calibrate medical gas concentration measurement devices.
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.
Cleared Devices (32)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K954804 | LUNG DIFFUSION MIXTURES | Mittler Supply, Inc. | Jan 25, 1996 | SESE |
| K954803 | BLOOD GAS MIXTURES | Mittler Supply, Inc. | Jan 25, 1996 | SESE |
| K954542 | LUNG DIFFUSION MIXTURE | Liquid Technology Corp. | Dec 22, 1995 | SESE |
| K952838 | MEDICAL MIXTURE-LUNG DIFFUSION GAS MIXTURES | Standard Welders Supply Co. | Sep 19, 1995 | SESE |
| K953934 | MED-TECH LUNG DIFFUSION MIXTURE | Medical Technical Gases Inc.. | Sep 18, 1995 | SESE |
| K953208 | MEDICAL MIXTURE-CLINICAL BLOOD GAS MIXTURES | Standard Welders Supply Co. | Jul 20, 1995 | SESE |
| K944998 | CALIBRATION GAS | Sunox, Inc. | Feb 3, 1995 | SESE |
| K944812 | CLINICAL BLOOD GAS MIXTURE | Laboratory & Specialty Gases, Inc. | Feb 1, 1995 | SESE |
| K942866 | CLINICAL BLOOD GAS MIXTURE | Nordan Smith Welding Supplies | Sep 1, 1994 | SESE |
| K932874 | BLOOD GAS MIXTURE | Tri-Gas, Inc. | Jan 27, 1994 | SESE |
| K935311 | CLINICAL BLOOD GAS | Acetylene Gas Co. | Dec 22, 1993 | SESE |
| K932520 | CALIBRATION GAS | Cryodyne Technologies, Inc. | Aug 19, 1993 | SESE |
| K924796 | LUNG DIFFUSION GAS MIXTURE | Gulf States Airgas | Dec 17, 1992 | SESE |
| K924795 | BLOOD GAS MIXTURE | Gulf States Airgas | Dec 17, 1992 | SESE |
| K911264 | CALIBRATION KIT | S & W Medico Teknik | Aug 2, 1991 | SESE |
| K911471 | LUNG DIFFUSION GAS MIXTURES | Norco, Inc. | Jun 18, 1991 | SESE |
| K902754 | ANESTHETIC GAS CALIBRATION MIXTURE | Liquid Air Corp. | Dec 19, 1990 | SESE |
| K882210 | MEDIBLEND (TM) LUNG DIFFUSION GAS MIXTURES | Linde Div. Union Carbide Corp. | Jun 21, 1988 | SESE |
| K873586 | LUNG DIFFUSION GAS | National Welders | Feb 12, 1988 | SESE |
| K874297 | CALIBRATION GAS FOR CARBON DIOXIDE MONITOR | Liquid Air Corp. | Dec 21, 1987 | SESE |
| K873587 | BLOOD ANALYSIS GAS | National Welders | Oct 30, 1987 | SESE |
| K871100 | O.1 TO 25.0% CARB. DIOX. U.S.P. BALANCE OXYGEN USP | Matheson Gas Products, Inc. | Apr 21, 1987 | SESE |
| K871103 | O.1 T0 40.0% CARBON DIOX. O.1 TO 90.0% OXY. U.S.P | Matheson Gas Products, Inc. | Apr 20, 1987 | SESE |
| K871102 | O.1 TO 50.0% CARBON DIOXIDE, USP BALANCE NITRO.,NF | Matheson Gas Products, Inc. | Apr 20, 1987 | SESE |
| K871101 | 0.1 TO 25.0% OXYGEN, USP, BALANCE NITROGEN, N.F. | Matheson Gas Products, Inc. | Apr 20, 1987 | SESE |
| K870139 | GAS, CALIBRATION, SPECIFIED CONCENTRATION | Portland Welding Supply, Inc. | Feb 10, 1987 | SESE |
| K863675 | CALIBRATION GAS FOR SERVO GAS MONITOR 120 | Siemens Elema AB | Nov 3, 1986 | SESE |
| K822764 | LUNG DIFFUSION MIXTURE | Liquid Carbonic Corp. | Oct 22, 1982 | SESE |
| K822763 | CLINICAL GAS MIXTURE-NON-FLAMMABLE | Liquid Carbonic Corp. | Oct 22, 1982 | SESE |
| K822762 | CLINICAL GAS MIXTURE-FLAMMABLE | Liquid Carbonic Corp. | Oct 22, 1982 | SESE |
| K822753 | BLOOD GAS MIXTURE | Liquid Carbonic Corp. | Oct 22, 1982 | SESE |
| K822752 | ANAEROBIC CARBON DIOXIDE | Liquid Carbonic Corp. | Oct 22, 1982 | SESE |
Top Applicants
- Liquid Carbonic Corp. — 5 clearances
- Matheson Gas Products, Inc. — 4 clearances
- Standard Welders Supply Co. — 2 clearances
- National Welders — 2 clearances
- Mittler Supply, Inc. — 2 clearances
