Phonic Ear, Inc.
Petaluma, CA, US
Phonic Ear, Inc. appears in FDA device records in Petaluma, CA. FDA records list 31 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 31
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 31 510(k) clearances for Phonic Ear, Inc. between 1982 and 2004. The busiest year on record is 1985, with 5. The most recent is 2004, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 3 |
| 1983 | 3 |
| 1984 | 1 |
| 1985 | 5 |
| 1986 | 4 |
| 1987 | 4 |
| 1988 | 2 |
| 1989 | 1 |
| 1991 | 1 |
| 1992 | 2 |
| 1994 | 1 |
| 1995 | 1 |
| 1998 | 2 |
| 2004 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K043090 | EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS | LZI | Substantially Equivalent | |
| K974658 | INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT | EPF | Substantially Equivalent | |
| K974287 | FM RECEIVER - AUDITORY TRAINER | EPF | Substantially Equivalent | |
| K950730 | GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM) | EPF | Substantially Equivalent | |
| K940313 | PHONIC EAR | EPF | Substantially Equivalent | |
| K923234 | PE 400IR, PE 400T, PE 400E | EPF | Substantially Equivalent | |
| K922720 | GROUP AUDITORY TRAINING SYSTEM | EPF | Substantially Equivalent | |
| K912356 | GROUP AUDITORY TRAINER,FM RECEIVER | EPF | Substantially Equivalent | |
| K893431 | AUDITORY TRAINER PE150R FM RECEIVER | EPF | Substantially Equivalent | |
| K882409 | PE100R FM RECEIVER USED W/PE100T FM TRANSMITTER | EPF | Substantially Equivalent | |
| K881099 | PE485R FM RECEIVER USED W/PE481FST FM TRANSMITTER | EPF | Substantially Equivalent | |
| K874304 | PHONIC EAR, PE 860C, PE 860PPC AND PE 860 PPCL | ESD | Substantially Equivalent | |
| K872474 | POST-AURICULAR HEARING AID MODEL PE 805 SCD2 | ESD | Substantially Equivalent | |
| K872473 | POST-AURICULAR HEARING AID MODEL PE 805CD2 | ESD | Substantially Equivalent | |
| K864672 | PHONIC EAR MODELS PE 811CS AND PE 811CST | ESD | Substantially Equivalent | |
| K862773 | PHONIC EAR, MODEL PE475R | EPF | Substantially Equivalent | |
| K862229 | PHONIC EAR PE 602 PPCS | ESD | Substantially Equivalent | |
| K862162 | PHONIC EAR, MODEL PE 1800 | ETW | Substantially Equivalent | |
| K861857 | PHONIC EAR | ETW | Substantially Equivalent | |
| K844862 | POST-AURICULAR HEARING AID MODEL PE 600PPCH | ESD | Substantially Equivalent | |
| K844863 | POST-SURICULAR HEARING AID PE 600CD | ESD | Substantially Equivalent | |
| K844859 | POST-AURICULAR HEARING AID MODEL PE 600 PPC | ESD | Substantially Equivalent | |
| K844861 | POST-AURICULAR HEARING AID MODEL PE 600PPCL | ESD | Substantially Equivalent | |
| K844860 | POST-AURICULAR HEARING AID MODEL PE 600CHD | ESD | Substantially Equivalent | |
| K840359 | POST-AURICULAR HEARING AID | ESD | Substantially Equivalent | |
| K832081 | PHONIC EAR PE 845PPC-D | ESD | Substantially Equivalent | |
| K832080 | PHONIC EAR PE 467R-PE 461T | EPF | Substantially Equivalent | |
| K830098 | PHONIC EAR | ESD | Substantially Equivalent | |
| K822779 | PHONIC EAR-PE 845-PPC | ESD | Substantially Equivalent | |
| K820172 | PHONIC EAR MODEL PE 810S | ESD | Substantially Equivalent | |
| K813583 | PHONIC EAR MODEL PE805CD | ESD | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Phonic Ear, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Phonic Ear, Inc.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain