The following data is part of a premarket notification filed by Ophthalmic Technologies, Inc. with the FDA for I-scan.
Device ID | K960622 |
510k Number | K960622 |
Device Name: | I-SCAN |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | OPHTHALMIC TECHNOLOGIES, INC. 37 KODIAK CRESCENT, UNIT 12 Downsview, Ontario, CA Mej 3e5 |
Contact | Rishard Weitz |
Correspondent | Rishard Weitz OPHTHALMIC TECHNOLOGIES, INC. 37 KODIAK CRESCENT, UNIT 12 Downsview, Ontario, CA Mej 3e5 |
Product Code | IYO |
CFR Regulation Number | 892.1560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-02-13 |
Decision Date | 1996-05-13 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
I-SCAN 76265044 2634591 Live/Registered |
Tekscan, Inc. 2001-05-31 |
I-SCAN 74640247 1965344 Dead/Expired |
OPHTHALMIC TECHNOLOGIES INC. 1995-03-01 |
I-SCAN 73547460 not registered Dead/Abandoned |
ORS AUTOMATION, INC. 1985-07-11 |