FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ELECTRIC I/V POLE OR EIVP2
K Number: K935003
·
Decision Jan 25, 1994
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
39
Applicant Total
21
Review Days
98
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Basic Information
- Device Name
- ELECTRIC I/V POLE OR EIVP2
- K Number
- K935003
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4360
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Optical Micro Systems, Inc.
- Date Received
- October 19, 1993
- Decision Date
- January 25, 1994
- 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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Other Clearances by Optical Micro Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K950218 | OMS SLIMLINE PHACO HANDPIECE | Jul 17, 1995 | Substantially Equivalent |
| K946054 | DIPLOMAX | Jul 11, 1995 | Substantially Equivalent |
| K935223 | OPHTHALMIC SURGICAL SYSTEM | Mar 14, 1994 | Substantially Equivalent |
| K935226 | I/V POLE | Feb 16, 1994 | Substantially Equivalent |
| K870068 | ASPIRATION REVERSAL CONTROL (ARC) MODULE | Feb 12, 1987 | Substantially Equivalent |
| K844373 | O.M.S. ULTRA-PHACO | Dec 19, 1985 | Substantially Equivalent |
| K844448 | OMS/GONVERS RETINAL PERFORATOR | Aug 21, 1985 | Substantially Equivalent |
| K844895 | OMS SILICONE OIL INJECTOR | Jun 24, 1985 | Substantially Equivalent |
| K844467 | OMS CRYO | Feb 22, 1985 | Substantially Equivalent |
| K844715 | VISC-X VITREOUS ASPIRATING & CUTTING INSTRUMENT SY | Jan 22, 1985 | Substantially Equivalent |