FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
METAVOX MV-1000 AUDITORY TRAINER
K Number: K832190
·
Decision Sep 12, 1983
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
31
Applicant Total
2
Review Days
66
Basic Information
- Device Name
- METAVOX MV-1000 AUDITORY TRAINER
- K Number
- K832190
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3320
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Metavox, Inc.
- Date Received
- July 8, 1983
- Decision Date
- September 12, 1983
- 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 Metavox, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K833152 | METAVOX MV-1000 HEARING AID | Dec 8, 1983 | Substantially Equivalent |