The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Nidek Monocular Indirect Ophthalmoscope.
Device ID | K843597 |
510k Number | K843597 |
Device Name: | NIDEK MONOCULAR INDIRECT OPHTHALMOSCOPE |
Classification | Ophthalmoscope, Ac-powered |
Applicant | NIDEK, INC. P.O. BOX 50488 Palo Alto , CA 94303 - |
Contact | Theresa M Newton |
Correspondent | Theresa M Newton NIDEK, INC. P.O. BOX 50488 Palo Alto , CA 94303 - |
Product Code | HLI |
CFR Regulation Number | 886.1570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-09-12 |
Decision Date | 1985-02-15 |