The following data is part of a premarket notification filed by Mentor O & O, Inc. with the FDA for Mentor B-vat(tm) Ii Video Tester.
| Device ID | K875112 |
| 510k Number | K875112 |
| Device Name: | MENTOR B-VAT(TM) II VIDEO TESTER |
| Classification | Chart, Visual Acuity |
| Applicant | MENTOR O & O, INC. 3000 LONGWATER DR. Norwell, MA 02061 -1672 |
| Contact | Mark Toma |
| Correspondent | Mark Toma MENTOR O & O, INC. 3000 LONGWATER DR. Norwell, MA 02061 -1672 |
| Product Code | HOX |
| CFR Regulation Number | 886.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-15 |
| Decision Date | 1988-03-08 |