The following data is part of a premarket notification filed by Electromed, Inc. with the FDA for Smartvest Airway Clearance System, Model Tl.
| Device ID | K053248 |
| 510k Number | K053248 |
| Device Name: | SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL |
| Classification | Percussor, Powered-electric |
| Applicant | ELECTROMED, INC. 103 EDGECUMBE DRIVE Mahtomedi, MN 55115 |
| Contact | Chet Sievert |
| Correspondent | Ned Devine INTERTEK TESTING SERVICES 70 CODMAN HILL RD. Boxborough, MA 01719 |
| Product Code | BYI |
| CFR Regulation Number | 868.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-11-21 |
| Decision Date | 2005-12-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B102070716S0100 | K053248 | 000 |
| B102070124S3440 | K053248 | 000 |
| B102070124S1580 | K053248 | 000 |
| B102070124S1240 | K053248 | 000 |
| B102070124S0320 | K053248 | 000 |
| B102070107S0200 | K053248 | 000 |
| B102070107S0100 | K053248 | 000 |
| B102070094S1110 | K053248 | 000 |
| B102070094S1100 | K053248 | 000 |
| B102070094S0110 | K053248 | 000 |
| B102070124S3920 | K053248 | 000 |
| B102070124S4100 | K053248 | 000 |
| B102070686S0100 | K053248 | 000 |
| B102070622S0100 | K053248 | 000 |
| B102070137S8400 | K053248 | 000 |
| B102070137S1240 | K053248 | 000 |
| B102070124S9990 | K053248 | 000 |
| B102070124S8400 | K053248 | 000 |
| B102070124S7920 | K053248 | 000 |
| B102070124S7840 | K053248 | 000 |
| B102070124S4840 | K053248 | 000 |
| B102070094S0100 | K053248 | 000 |