Panels › Anesthesiology › Product code NVP · Class 2
Holding Chambers, Direct Patient Interface
Regulation 868.5630
0510(k)s in 12 months (16 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in NVP
| Company | 510(k)s | Recalls |
|---|---|---|
| Trudell Medical Intl. | 4 | 0 |
| Cardinal Health Inc. | 0 | 2 |
| Fsc Laboratories, Inc. | 1 | 1 |
| Medical Developments International | 2 | 0 |
| Thayer Medical Corporation | 2 | 0 |
| Trudell Medical International | 2 | 0 |
| Activaero America, Inc. | 1 | 0 |
| Aga Plastic Ind. Com. Ltda. | 1 | 0 |
| Inspirx, Inc. | 1 | 0 |
| Koo (Shanghai) Industries Co., Ltd. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 16, 2021 | Cardinal Health Inc. OPTICHAMBER DIAMOND SPACER WITH LARGE MASK
Item Number: 4742326 Open, Classified |
NVP | K110293 |
| Mar 16, 2021 | Cardinal Health Inc. AEROCHAMBER PLS W/MASK LRG BLU
Item Number: 1496033 Open, Classified |
NVP | K181649 |
| Jun 15, 2016 | FSC Laboratories, Inc Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Metered Dose Inhalers(pMDIs). Terminated |
NVP | K140062 |
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