FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
POST-AURICULAR HEARING AID MODEL PE 600CHD
K Number: K844860
·
Decision Mar 27, 1985
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
1366
Applicant Total
31
Review Days
103
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Basic Information
- Device Name
- POST-AURICULAR HEARING AID MODEL PE 600CHD
- K Number
- K844860
- 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
- December 14, 1984
- Decision Date
- March 27, 1985
- 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 |
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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 |