FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMPEDANCE METER ON-1
K Number: K823227
·
Decision Nov 22, 1982
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
69
Applicant Total
12
Review Days
24
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Basic Information
- Device Name
- IMPEDANCE METER ON-1
- K Number
- K823227
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.1090
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Kells Medical, Inc.
- Date Received
- October 29, 1982
- Decision Date
- November 22, 1982
- Product Code
- ETY
- 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 |
|---|---|---|---|
| ETY | Tester, Auditory Impedance | FDA class 2 | Ear, Nose, Throat |
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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 |
| K823118 | SAY | Jan 7, 1983 | Substantially Equivalent |