510(k) K911471
- Device
- LUNG DIFFUSION GAS MIXTURES
- Applicant
- NORCO, INC.
- 510(k) number
- K911471
- Product code
- BXK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-06-18
- Date received
- 1991-04-03
- Regulation
- 868.6400
- Classification name
- Gas, Calibration (specified Concentration)
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- LYLE R FEELY
- Address
- 1121 W. Amity Boise ID US 83705 83705
FDA Registration Numbers#
- 1218978
- 2518435
- 2127862
- 3011682
- 1020303
- 2221310
- 2127612
- 2432235
- 3014527933
- 1454831
- 1944017
- 3009352626
- 1620065
- 2522976
- 2529486
- 1619650
- 1717226
- 3008931060
- 3024515
- 3016558817
- 3000126629
- 1715731
- 9610816
- 2024781
- 2648972
- 2015940
- 2124914
- 2518945
- 1033831
- 1645341
- 3020756
- 1056791
- 1063155
- 3007313217
- 9610105
- 2250062
- 3002637618
- 1217333
- 1250022
- 1627208
- 1625735
- 1950212
- 1225722
- 1648589
- 3023487442
- 1419818
- 1946773
- 2911183
- 1150053
- 3004931173
- 1835566
- 3009837363
- 3009675181
- 1054077
- 3020693
- 1054016
- 2523408
- 1717152
- 2025895
- 2350043
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code BXK #
| 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 |
Legacy Summary#
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FDA Review#
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