LUNG DIFFUSION GAS MIXTURES
FDA 510(k) clearance K911471 · decided 1991-06-18
Clearance details
- K-number
- K911471
- Device name
- LUNG DIFFUSION GAS MIXTURES
- Applicant
- Norco, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-04-03
- Decision date
- 1991-06-18
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- BXK
- Device class
- 1
- Regulation number
- 868.6400
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Boise, ID, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BLOOD GAS MIXTURES (K954803) | Mittler Supply, Inc. | 1996-01-25 |
| LUNG DIFFUSION MIXTURES (K954804) | Mittler Supply, Inc. | 1996-01-25 |
| LUNG DIFFUSION MIXTURE (K954542) | Liquid Technology Corp. | 1995-12-22 |
| MEDICAL MIXTURE-LUNG DIFFUSION GAS MIXTURES (K952838) | Standard Welders Supply Co. | 1995-09-19 |
| MED-TECH LUNG DIFFUSION MIXTURE (K953934) | Medical Technical Gases Inc.. | 1995-09-18 |
| MEDICAL MIXTURE-CLINICAL BLOOD GAS MIXTURES (K953208) | Standard Welders Supply Co. | 1995-07-20 |
| CALIBRATION GAS (K944998) | Sunox, Inc. | 1995-02-03 |
| CLINICAL BLOOD GAS MIXTURE (K944812) | Laboratory & Specialty Gases, Inc. | 1995-02-01 |
| CLINICAL BLOOD GAS MIXTURE (K942866) | Nordan Smith Welding Supplies | 1994-09-01 |
| BLOOD GAS MIXTURE (K932874) | Tri-Gas, Inc. | 1994-01-27 |
| CLINICAL BLOOD GAS (K935311) | Acetylene Gas Co. | 1993-12-22 |
| CALIBRATION GAS (K932520) | Cryodyne Technologies, Inc. | 1993-08-19 |
Recalls involving this device
No recalls on record reference this clearance.