K935003 is an FDA 510(k) clearance for the ELECTRIC I/V POLE OR EIVP2. This device is classified as a Device, Irrigation, Ocular Surgery (Class I - General Controls, product code KYG).
Submitted by Optical Micro Systems, Inc. (North Andover, US). The FDA issued a Cleared decision on January 25, 1994, 98 days after receiving the submission on October 19, 1993.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4360.
| 510(k) Number | K935003 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 19, 1993 |
| Decision Date | January 25, 1994 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | KYG — Device, Irrigation, Ocular Surgery |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4360 |