FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PHONIC EAR
K Number: K830098
·
Decision Feb 1, 1983
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
1366
Applicant Total
31
Review Days
21
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PHONIC EAR
- K Number
- K830098
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Phonic Ear, Inc.
- Date Received
- January 11, 1983
- Decision Date
- February 1, 1983
- Product Code
- ESD
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ESD | Hearing Aid, Air-Conduction, Prescription | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ESD), ordered by most recent decision date.
Lyric4 Hearing Aid
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
LYRIC2
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
LYRIC HEARING AID
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
INSOUND XT SERIES HEARING AID
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Other Clearances by Phonic Ear, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K043090 | EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS | Dec 23, 2004 | Substantially Equivalent |
| K974658 | INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT | Feb 25, 1998 | Substantially Equivalent |
| K974287 | FM RECEIVER - AUDITORY TRAINER | Feb 10, 1998 | Substantially Equivalent |
| K950730 | GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM) | Jun 30, 1995 | Substantially Equivalent |
| K940313 | PHONIC EAR | Mar 22, 1994 | Substantially Equivalent |
| K923234 | PE 400IR, PE 400T, PE 400E | Sep 29, 1992 | Substantially Equivalent |
| K922720 | GROUP AUDITORY TRAINING SYSTEM | Aug 24, 1992 | Substantially Equivalent |
| K912356 | GROUP AUDITORY TRAINER,FM RECEIVER | Aug 15, 1991 | Substantially Equivalent |
| K893431 | AUDITORY TRAINER PE150R FM RECEIVER | Aug 21, 1989 | Substantially Equivalent |
| K882409 | PE100R FM RECEIVER USED W/PE100T FM TRANSMITTER | Jul 5, 1988 | Substantially Equivalent |