FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SAY
K Number: K823118
·
Decision Jan 7, 1983
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
12
Applicant Total
12
Review Days
78
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Basic Information
- Device Name
- SAY
- K Number
- K823118
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3375
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Kells Medical, Inc.
- Date Received
- October 21, 1982
- Decision Date
- January 7, 1983
- 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
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DENRICK SPEECH AID (DR-1)
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LECTRO-LARYNX
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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
Other Clearances by Kells Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K926333 | CPR PLUS | Nov 8, 1993 | Substantially Equivalent |
| K890093 | PVC EMPTY SOLUTION CONTAINER ENTERAL PUMP SET | Jul 24, 1989 | Substantially Equivalent |
| K890095 | PVC EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET | May 24, 1989 | Substantially Equivalent |
| K890094 | EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET | May 24, 1989 | Substantially Equivalent |
| K861972 | DERMISTRIP | Jun 27, 1986 | Substantially Equivalent for Some Indications |
| K844463 | DERMIDRESS | Jan 8, 1985 | Substantially Equivalent |
| K844072 | DERMIZIP SKIN CLOSURE DEVICE | Nov 5, 1984 | Substantially Equivalent |
| K832678 | PHONATORY FUNCTION ANALYZER PS-77 | Mar 7, 1984 | Substantially Equivalent |
| K832667 | LUCAE'S EAR & NASAL APPLICATORS | Sep 29, 1983 | Substantially Equivalent |
| K823226 | SN-100 DOCTOR'S ROUND | Nov 22, 1982 | Substantially Equivalent |