The following data is part of a premarket notification filed by Jointvue Llc with the FDA for 3d Echo.
Device ID | K172513 |
510k Number | K172513 |
Device Name: | 3D Echo |
Classification | System, Image Processing, Radiological |
Applicant | JointVue LLC 2099 Thunderhead Rd., Suite 104 Knoxville, TN 37922 |
Contact | Mohamed R. Mahfouz |
Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2017-08-21 |
Decision Date | 2017-09-14 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00850014885007 | K172513 | 000 |