The following data is part of a premarket notification filed by Ophthalmic Technologies, Inc. with the FDA for 3d I-scan.
Device ID | K974522 |
510k Number | K974522 |
Device Name: | 3D I-SCAN |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | OPHTHALMIC TECHNOLOGIES, INC. 377 RT 17 S Hasbrouck Heights, NJ 07604 |
Contact | George Myers |
Correspondent | George Myers OPHTHALMIC TECHNOLOGIES, INC. 377 RT 17 S Hasbrouck Heights, NJ 07604 |
Product Code | IYO |
CFR Regulation Number | 892.1560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-12-02 |
Decision Date | 1998-02-25 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
3D I-SCAN 74640244 2204673 Dead/Cancelled |
OPHTHALMIC TECHNOLOGIES INC. 1995-03-01 |