The following data is part of a premarket notification filed by Mira, Inc. with the FDA for Schepens-yoshida Video Binocular Indirect Ophthalmscope.
Device ID | K951728 |
510k Number | K951728 |
Device Name: | SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE |
Classification | Ophthalmoscope, Ac-powered |
Applicant | MIRA, INC. 87 RUMFORD AVE. Waltham, MA 02453 -3846 |
Contact | Roger R O'brien |
Correspondent | Roger R O'brien MIRA, INC. 87 RUMFORD AVE. Waltham, MA 02453 -3846 |
Product Code | HLI |
CFR Regulation Number | 886.1570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-04-13 |
Decision Date | 1997-03-19 |