The following data is part of a premarket notification filed by Vucomp, Inc. with the FDA for M-vu Cad Station.
Device ID | K061160 |
510k Number | K061160 |
Device Name: | M-VU CAD STATION |
Classification | System, Image Processing, Radiological |
Applicant | VUCOMP, INC. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
Contact | Susan D Goldstein-falk |
Correspondent | Susan D Goldstein-falk VUCOMP, INC. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-04-26 |
Decision Date | 2006-06-09 |
Summary: | summary |