FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
P.O. VOX
K Number: K860993
·
Decision Apr 25, 1986
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
12
Applicant Total
3
Review Days
39
Basic Information
- Device Name
- P.O. VOX
- K Number
- K860993
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3375
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Bloomfield Research and Development, Inc.
- Date Received
- March 17, 1986
- Decision Date
- April 25, 1986
- Product Code
- ESE
- 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 |
|---|---|---|---|
| ESE | Larynx, Artificial (Battery-Powered) | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ESE), ordered by most recent decision date.
NU-VOIS BATTERY POWERED ARTIFICIAL LARYNX
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
DENRICK SPEECH AID (DR-1)
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
LECTRO-LARYNX
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
AMERICAN ARTIFICIAL LARYNX
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEM
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
VOX COMPANION
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat