The following data is part of a premarket notification filed by Electromed, Inc. with the FDA for Smartvest Airway Clearance System.
| Device ID | K132794 |
| 510k Number | K132794 |
| Device Name: | SMARTVEST AIRWAY CLEARANCE SYSTEM |
| Classification | Percussor, Powered-electric |
| Applicant | ELECTROMED, INC. 502 SIXTH AVE. N.W. New Prague, MN 56071 |
| Contact | Chet Sievert |
| Correspondent | Chet Sievert ELECTROMED, INC. 502 SIXTH AVE. N.W. 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 | 2013-09-06 |
| Decision Date | 2013-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B10209488S1510 | K132794 | 000 |
| B102090488S1310 | K132794 | 000 |
| B102090488S1300 | K132794 | 000 |
| B102090488S1110 | K132794 | 000 |
| B102090488S1100 | K132794 | 000 |
| B102090488S0510 | K132794 | 000 |
| B102090488S0500 | K132794 | 000 |
| B102090488S0410 | K132794 | 000 |
| B102090488S0400 | K132794 | 000 |
| B102090488S0310 | K132794 | 000 |
| B102090488S0300 | K132794 | 000 |
| B102090488S0210 | K132794 | 000 |
| B102090488S0200 | K132794 | 000 |
| B102090488S0110 | K132794 | 000 |
| B102090488S0100 | K132794 | 000 |
| B102090488S1400 | K132794 | 000 |
| B102090488S1410 | K132794 | 000 |
| B102090488S1500 | K132794 | 000 |
| B102090740S8400 | K132794 | 000 |
| B102090683S0100 | K132794 | 000 |
| B102090649S0800 | K132794 | 000 |
| B102090649S0700 | K132794 | 000 |
| B102090649S0600 | K132794 | 000 |
| B102090649S0500 | K132794 | 000 |
| B102090649S0400 | K132794 | 000 |
| B102090649S0300 | K132794 | 000 |
| B102090649S0200 | K132794 | 000 |
| B102090649S0100 | K132794 | 000 |
| B102090579S0100 | K132794 | 000 |
| B102090535S0100 | K132794 | 000 |
| B102090504S0100 | K132794 | 000 |
| B102090499S8400 | K132794 | 000 |
| B102090766S0100 | K132794 | 000 |