FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PHONIC EAR
K Number: K780936
·
Decision Jun 22, 1978
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
31
Applicant Total
10
Review Days
14
Basic Information
- Device Name
- PHONIC EAR
- K Number
- K780936
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3320
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Hc Electronics
- Date Received
- June 8, 1978
- Decision Date
- June 22, 1978
- Product Code
- EPF
- 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 |
|---|---|---|---|
| EPF | Hearing Aid, Group And Auditory Trainer | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EPF), ordered by most recent decision date.
HYPERSOUND AUDIO SYSTEM (HSS)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
FM RECEIVER - AUDITORY TRAINER
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
WILLIAMS SOUND, PERSONAL FM, HEARING HELPER
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
WILLIAMS SOUND, PERSONAL FM, HEARING HELPER
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by Hc Electronics
| K Number | Device Name | ||
|---|---|---|---|
| K810031 | STEREO AUDITORY TRAINER (MODEL PM228) | Mar 4, 1981 | Substantially Equivalent |
| K810030 | POST-AURICULAR HEARING AID (#PE830) | Jan 14, 1981 | Substantially Equivalent |
| K800340 | PHONIC EAR, MODEL 841L | Feb 26, 1980 | Substantially Equivalent |
| K782053 | HEARING AID, POST-AURICULAR | Dec 15, 1978 | Substantially Equivalent |
| K780363 | PHONIC EAR | Mar 21, 1978 | Substantially Equivalent |
| K772347 | PHONIC MIRROR HANDIVOICE MODEL 120 | Jan 11, 1978 | Substantially Equivalent |
| K772346 | PHONIC MIRROR HANDIVOCIE MODEL 110 | Jan 11, 1978 | Substantially Equivalent |
| K771357 | GROUP AUDITORY TRAINER HC 431R | Jul 29, 1977 | Substantially Equivalent |
| K771356 | POST-AURICULAR HEARING AID HC 880 | Jul 29, 1977 | Substantially Equivalent |