K952838 is an FDA 510(k) clearance for the MEDICAL MIXTURE-LUNG DIFFUSION GAS MIXTURES. This device is classified as a Gas, Calibration (specified Concentration) (Class I - General Controls, product code BXK).
Submitted by Standard Welders Supply Co. (Memphis, US). The FDA issued a Cleared decision on September 19, 1995, 92 days after receiving the submission on June 19, 1995.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.6400.
| 510(k) Number | K952838 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 19, 1995 |
| Decision Date | September 19, 1995 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BXK — Gas, Calibration (specified Concentration) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.6400 |