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 |