The following data is part of a premarket notification filed by Sonomed, Inc. with the FDA for Axis Image Management System.
Device ID | K171098 |
510k Number | K171098 |
Device Name: | AXIS Image Management System |
Classification | System, Image Management, Ophthalmic |
Applicant | Sonomed, Inc. 1979 Marcus Ave, Suite C105 New Hyde Park, NY 11042 |
Contact | Mark Wallace |
Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
Product Code | NFJ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2017-04-13 |
Decision Date | 2017-05-02 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00896100002002 | K171098 | 000 |