The following data is part of a premarket notification filed by Lsvt Global, Llc with the FDA for Lsvt C Or Lsvt Companion, Model V.1.
| Device ID | K091682 |
| 510k Number | K091682 |
| Device Name: | LSVT C OR LSVT COMPANION, MODEL V.1 |
| Classification | Aids, Speech Training For The Hearing Impaired (ac-powered And Patient-contact) |
| Applicant | LSVT GLOBAL, LLC 6900 E SUNRISE DRIVE SUITE 120 #241 Tucson, AZ 85750 |
| Contact | David H Mcfarland |
| Correspondent | David H Mcfarland LSVT GLOBAL, LLC 6900 E SUNRISE DRIVE SUITE 120 #241 Tucson, AZ 85750 |
| Product Code | LEZ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-10 |
| Decision Date | 2009-08-20 |
| Summary: | summary |