VISIVOX, MODEL V-2
FDA 510(k) clearance K982396 · decided 1998-09-14
Clearance details
- K-number
- K982396
- Device name
- VISIVOX, MODEL V-2
- Applicant
- Rsq, LLC
- Decision
- Substantially Equivalent
- Date received
- 1998-07-09
- Decision date
- 1998-09-14
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- LEZ
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Claremont, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LSVT C OR LSVT COMPANION, MODEL V.1 (K091682) | Lsvt Global, LLC | 2009-08-20 |
| RION ELECTRO-PALATOGRAPH MODEL DP-01 (K802870) | Kindel & Anderson | 1980-12-17 |
Recalls involving this device
No recalls on record reference this clearance.