The following data is part of a premarket notification filed by Vitacon Medical Inc. with the FDA for Vitascan Lt Scanmaster.
Device ID | K121689 |
510k Number | K121689 |
Device Name: | VITASCAN LT SCANMASTER |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | VITACON MEDICAL INC. 4020 Viking Way Unit 130 Richmond, CA V6v 2l4 |
Contact | Ron Evans |
Correspondent | Ron Evans VITACON MEDICAL INC. 4020 Viking Way Unit 130 Richmond, CA V6v 2l4 |
Product Code | IYO |
CFR Regulation Number | 892.1560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-06-07 |
Decision Date | 2012-09-19 |
Summary: | summary |