Panels › Anesthesiology › Product code BYF · Class 1
Mask, Oxygen, Low Concentration, Venturi
Regulation 868.5600
0510(k)s in 12 months (19 all time)
0recalls in 12 months (3 all time)
1recalls that name a 510(k)
Top companies in BYF
| Company | 510(k)s | Recalls |
|---|---|---|
| Airlife, Inc. | 5 | 0 |
| Dhd Medical Products Div. Diemolding Corp. | 2 | 0 |
| Hospitak, Inc. | 2 | 0 |
| Smiths Medical | 0 | 2 |
| Todd Industries, Inc. | 2 | 0 |
| Ashai Co. , Ltd. | 1 | 0 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 0 |
| Dadsun Corp., Ltd. | 1 | 0 |
| Flexicare Medical, Ltd. | 1 | 0 |
| Landmark Plastics | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 26, 2011 | Salter Laboratories, Division of Regulatory Affairs Mask adult, elastic strap style, Percent-O2 Lock air entrainment system, w/7' tube (Linde) - 50/cs;
Salter Labs, Arvin, CA 93203
Intended usage: respiratory therapy. Terminated |
BYF | K772127 |
| Jun 24, 2011 | Smiths Medical Value Pack General Anesthesia Kit, (containing Reorder Number: 001421 Oxygen Face Mask)
Reorder Number: VP1302
For acute use, e.g. Post-op recovery, minimal trauma, patient transfer; used for patient Terminated |
BYF | None listed |
| Jun 24, 2011 | Smiths Medical First Breath Adult Venturi Oxygen Mask with Corrugated Tubing, O2 Diluter Jets (6), Oxygen Tubing, and Nebulizer Hood. (Non-latex) 50/CA
Reorder Number: 002610
For acute use, e.g. Post-op recovery, m Terminated |
BYF | None listed |
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