The following data is part of a premarket notification filed by Neitz Instruments Company, Ltd. with the FDA for Neitz Halogen Binocular Indirect Ophthalmoscope Io-h.
| Device ID | K942713 |
| 510k Number | K942713 |
| Device Name: | NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-H |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | NEITZ INSTRUMENTS COMPANY, LTD. 1050 CONNECTICUT AVE., N.W. Washington, DC |
| Contact | Tracy Berns |
| Correspondent | Tracy Berns NEITZ INSTRUMENTS COMPANY, LTD. 1050 CONNECTICUT AVE., N.W. Washington, DC |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-09 |
| Decision Date | 1994-08-05 |