The following data is part of a premarket notification filed by Westmed, Inc. with the FDA for Vibralung Acoustical Percussor.
| Device ID | K133057 |
| 510k Number | K133057 |
| Device Name: | VIBRALUNG ACOUSTICAL PERCUSSOR |
| Classification | Percussor, Powered-electric |
| Applicant | Westmed, Inc. 5580 S. NOGALES HIGHWAY Tucson, AZ 85706 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden Westmed, Inc. 5580 S. NOGALES HIGHWAY Tucson, AZ 85706 |
| Product Code | BYI |
| CFR Regulation Number | 868.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-27 |
| Decision Date | 2014-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10709078002417 | K133057 | 000 |
| 00709078001345 | K133057 | 000 |
| 10709078001359 | K133057 | 000 |
| 00709078001369 | K133057 | 000 |
| 00709078001376 | K133057 | 000 |
| 10709078001502 | K133057 | 000 |
| 00709078001512 | K133057 | 000 |
| 10709078001526 | K133057 | 000 |
| 00709078001536 | K133057 | 000 |
| 10709078001540 | K133057 | 000 |
| 00709078002397 | K133057 | 000 |
| 00709078002403 | K133057 | 000 |
| 00709078001338 | K133057 | 000 |