FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SN-100 DOCTOR'S ROUND
K Number: K823226
·
Decision Nov 22, 1982
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
31
Applicant Total
12
Review Days
24
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Basic Information
- Device Name
- SN-100 DOCTOR'S ROUND
- K Number
- K823226
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.5300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Kells Medical, Inc.
- Date Received
- October 29, 1982
- Decision Date
- November 22, 1982
- Product Code
- ETF
- 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 |
|---|---|---|---|
| ETF | Unit, Examining/Treatment, Ent | FDA class 1 | 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 |