Panels › Anesthesiology › Product code KFZ · Class 1
Humidifier, Non-Direct Patient Interface (Home-Use)
Regulation 868.5460
0510(k)s in 12 months (20 all time)
0recalls in 12 months (3 all time)
1recalls that name a 510(k)
Top companies in KFZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Airlife, Inc. | 2 | 0 |
| Associated Mills, Inc. | 2 | 0 |
| Kaz, Inc. | 1 | 1 |
| Mistogen Equipment Co. | 2 | 0 |
| Ascot Pharmaceuticals, Inc. | 1 | 0 |
| Bigwall Enterprises | 0 | 1 |
| Cardinal Health Inc. | 0 | 1 |
| Douglas Products | 1 | 0 |
| Hankscraft Div. of Gerber Products Co. | 1 | 0 |
| Med USA | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 16, 2021 | Cardinal Health Inc. VAPORIZER VICKS 1.5GAL
Item Number: 2354942 Open, Classified |
KFZ | K950116 |
| Nov 20, 2015 | Bigwall Enterprises WARM STEAM Personal Steam Inhaler-Adjustable control to regulate flow of steam Soft touch facial & nasal masks"
Product labeling reads in part: "Well at Walgreens***WARM
Helps relieve symptoms of stu Terminated |
KFZ | None listed |
| May 8, 2003 | KAZ Inc. Vicks brand Warm Mist Humidifier, Model V610, ''Pure Warm Moisturizer for Soothing Relief of Cold and Flu Symptoms'' sold over the counter. Firm on the label: Distributed by Kaz Inc., under license Terminated |
KFZ | None listed |
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