The following data is part of a premarket notification filed by Heine Usa, Ltd. with the FDA for Heine Lambda 100.
| Device ID | K944156 |
| 510k Number | K944156 |
| Device Name: | HEINE LAMBDA 100 |
| Classification | Chart, Visual Acuity |
| Applicant | HEINE USA, LTD. 3500 REGENCY PARKWAY SUITE"C" Cary, NC 27511 -8569 |
| Contact | Ben S Jean |
| Correspondent | Ben S Jean HEINE USA, LTD. 3500 REGENCY PARKWAY SUITE"C" Cary, NC 27511 -8569 |
| Product Code | HOX |
| CFR Regulation Number | 886.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-26 |
| Decision Date | 1995-01-12 |