The following data is part of a premarket notification filed by Permobil A.b. with the FDA for Ober2 Monitor, Eye Movement (ophthalmic).
| Device ID | K902954 |
| 510k Number | K902954 |
| Device Name: | OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC) |
| Classification | Aspirator, Endocervical |
| Applicant | PERMOBIL A.B. 30 RAY AVE. Burlington, MA 01803 |
| Contact | Finkelstein, Md |
| Correspondent | Finkelstein, Md PERMOBIL A.B. 30 RAY AVE. Burlington, MA 01803 |
| Product Code | HFC |
| CFR Regulation Number | 884.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-05 |
| Decision Date | 1990-08-23 |