FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS
K Number: K043090
·
Decision Dec 23, 2004
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
6
Applicant Total
31
Review Days
45
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Basic Information
- Device Name
- EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS
- K Number
- K043090
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3320
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Phonic Ear, Inc.
- Date Received
- November 8, 2004
- Decision Date
- December 23, 2004
- Product Code
- LZI
- 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 |
|---|---|---|---|
| LZI | Device, Assistive Listening | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LZI), ordered by most recent decision date.
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Other Clearances by Phonic Ear, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K881099 | PE485R FM RECEIVER USED W/PE481FST FM TRANSMITTER | Jun 7, 1988 | Substantially Equivalent |