The following data is part of a premarket notification filed by Electromed, Inc. with the FDA for Electromed Smartvest Airway Clearance System.
| Device ID | K222496 |
| 510k Number | K222496 |
| Device Name: | Electromed SmartVest Airway Clearance System |
| Classification | Percussor, Powered-electric |
| Applicant | Electromed, Inc. 500 Sixth Ave NW New Prague, MN 56071 |
| Contact | Gregory Spurlock |
| Correspondent | Gregory Spurlock Electromed, Inc. 500 Sixth Ave NW New Prague, MN 56071 |
| Product Code | BYI |
| CFR Regulation Number | 868.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-18 |
| Decision Date | 2022-11-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B102125003S0200 | K222496 | 000 |
| B102125011S0100 | K222496 | 000 |
| B102125003S0210 | K222496 | 000 |