Frye Electronics, Inc.
Beaverton, OR, US
FRYE ELECTRONICS, INC. appears in FDA device records in Beaverton, OR. FDA records list 13 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Frye Electronics, Inc. between 1980 and 2013. The busiest year on record is 1980, with 2. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 2 |
| 1984 | 1 |
| 1985 | 1 |
| 1986 | 1 |
| 1987 | 1 |
| 1990 | 1 |
| 1991 | 1 |
| 1994 | 1 |
| 1998 | 1 |
| 2002 | 1 |
| 2009 | 1 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K123701 | HEARLAB ACA | GWJ | Substantially Equivalent | |
| K093006 | FONIX ,MODEL 8000 | ETW | Substantially Equivalent | |
| K022510 | FONIX, MODEL 7000 | ETW | Substantially Equivalent | |
| K980377 | FONIX FP35 HEARING AID ANALYZER | ETW | Substantially Equivalent | |
| K935400 | FONIX 3500 HEARING AID ANALYZER | ETW | Substantially Equivalent | |
| K913221 | TYPE FA10 AUDIOMETER | EWO | Substantially Equivalent | |
| K895383 | TYPE FP40 DIGITAL HEARING AID ANALYZER | ETW | Substantially Equivalent | |
| K872242 | TYPE 6400 REAL EAR HEARING AID ANALYZER | ETW | Substantially Equivalent | |
| K861571 | TYPE 6500 HEARING AID ANALYZER | ETW | Substantially Equivalent | |
| K850918 | TYPE FP30 DIGITAL HEARING AID ANALYZER | ETW | Substantially Equivalent | |
| K833883 | DIGITAL AUDIOMETER/HEARING AID 3100 | EWO | Substantially Equivalent | |
| K801905 | FONIX TYPE 5100 HEARING AID ANALYZER | ETW | Substantially Equivalent | |
| K800630 | TYPE 4000 TRANSCUTANEOUS ELEC. STIM. | GZJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3018639 | 3018639 | FRYE ELECTRONICS, INC. | 8279 Sw Cirrus Dr, Beaverton, OR 97008 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain