FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC)
K Number: K861013
·
Decision Mar 31, 1986
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
39
Applicant Total
17
Review Days
13
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Basic Information
- Device Name
- ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC)
- K Number
- K861013
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4360
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Ameritek, Inc.
- Date Received
- March 18, 1986
- Decision Date
- March 31, 1986
- Product Code
- KYG
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| KYG | Device, Irrigation, Ocular Surgery | FDA class 1 | Ophthalmic |
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