The following data is part of a premarket notification filed by Ophthalmic Technologies, Inc. with the FDA for I-scope Ophthalmic Endoscope.
Device ID | K971679 |
510k Number | K971679 |
Device Name: | I-SCOPE OPHTHALMIC ENDOSCOPE |
Classification | Endoilluminator |
Applicant | OPHTHALMIC TECHNOLOGIES, INC. 37 KODIAK CRESCENT UNIT 16 Downsview, Ontario, CA M3j 3e5 |
Contact | Richard Weitz |
Correspondent | Richard Weitz OPHTHALMIC TECHNOLOGIES, INC. 37 KODIAK CRESCENT UNIT 16 Downsview, Ontario, CA M3j 3e5 |
Product Code | MPA |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-05-07 |
Decision Date | 1997-06-25 |
Summary: | summary |