The following data is part of a premarket notification filed by Electromed, Inc. with the FDA for Medpulse Respiratory Vest System, Model 1000.
| Device ID | K982889 |
| 510k Number | K982889 |
| Device Name: | MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000 |
| Classification | Percussor, Powered-electric |
| Applicant | ELECTROMED, INC. 14920 MINNETONKA IND. RD. Minnetonka, MN 55345 |
| Contact | Chet Sievert |
| Correspondent | Chet Sievert ELECTROMED, INC. 14920 MINNETONKA IND. RD. Minnetonka, MN 55345 |
| Product Code | BYI |
| CFR Regulation Number | 868.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-17 |
| Decision Date | 1999-06-01 |
| Summary: | summary |