Panels › Anesthesiology › Product code BYI · Class 2
Percussor, Powered-Electric
Regulation 868.5665
1510(k)s in 12 months (58 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in BYI
| Company | 510(k)s | Recalls |
|---|---|---|
| Electromed, Inc. | 5 | 0 |
| American Biosystems, Inc. | 4 | 0 |
| Dymedso, Inc. | 3 | 0 |
| Strom Corp. | 3 | 0 |
| Advanced Respiratory | 2 | 0 |
| Bradstreet Clinical Research Assoc., Inc. | 2 | 0 |
| Cussionair Therapy Products, Inc. | 2 | 0 |
| Hudson Oxygen Therapy Sales Co. | 2 | 0 |
| Med Systems | 2 | 0 |
| Airphysio Pty, Ltd. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 31, 2021 | Smiths Medical ASD Inc. Palm Cups - Product Usage: intended to be used to percuss the chest wall to mobilize the secretions within the bronchial tree. Terminated |
BYI | K812166 |
| Sep 15, 2017 | HILL-ROM MANUFACTURING, INC. Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue tooth capability only) and PMACS1WI (has WIFI capability). The firm name on the label is Hill-Rom Services Pte. Ltd., Terminated |
BYI | K163378 |
| Jan 22, 2015 | Aptalis Pharmatech Inc. FLUTTER Percussor respiratory device, packaged one unit per clear plastic package.
Product Usage:
Product is a percussor device, intended to be used as a mucus clearance device for patients with mu Terminated |
BYI | K946083 |
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