The following data is part of a premarket notification filed by Notal Vision, Inc. with the FDA for Mascular Computerized Psychophysical Test (mcpt).
| Device ID | K014044 |
| 510k Number | K014044 |
| Device Name: | MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT) |
| Classification | Grid, Amsler |
| Applicant | NOTAL VISION, INC. 12300 TWINBROOK PKWAY; STE 625 Rockville, MD 20852 |
| Contact | Richard E Lippman |
| Correspondent | Richard E Lippman NOTAL VISION, INC. 12300 TWINBROOK PKWAY; STE 625 Rockville, MD 20852 |
| Product Code | HOQ |
| CFR Regulation Number | 886.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-07 |
| Decision Date | 2002-03-04 |
| Summary: | summary |