VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229
FDA 510(k) clearance K935701 · decided 1994-05-10
Clearance details
- K-number
- K935701
- Device name
- VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229
- Applicant
- Starkey Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-11-30
- Decision date
- 1994-05-10
- Days to decision
- 161 days
- Clearance type
- Traditional
- Product code
- LXB
- Device class
- 2
- Regulation number
- 874.3302
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Eden Prairie, MN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Starkey Laboratories
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.