The following data is part of a premarket notification filed by Haag-streit Ag with the FDA for Eyesuite Imaging.
| Device ID | K142423 |
| 510k Number | K142423 |
| Device Name: | EyeSuite Imaging |
| Classification | System, Image Management, Ophthalmic |
| Applicant | HAAG-STREIT AG GARDENSTADTSTRASSE 10 Koeniz, Bern, CH Ch-3098 |
| Contact | Oscar Banz |
| Correspondent | Dawn M Tibodeau TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | NFJ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-08-28 |
| Decision Date | 2014-09-10 |
| Summary: | summary |