K902954 is an FDA 510(k) clearance for the OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC). This device is classified as a Aspirator, Endocervical (Class II - Special Controls, product code HFC).
Submitted by Permobil AB (Burlington, US). The FDA issued a Cleared decision on August 23, 1990, 49 days after receiving the submission on July 5, 1990.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1050.
| 510(k) Number | K902954 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 1990 |
| Decision Date | August 23, 1990 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HFC — Aspirator, Endocervical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1050 |