The following data is part of a premarket notification filed by Ultralinq Healthcare Solutions, Inc. with the FDA for Ultralinq.
Device ID | K143176 |
510k Number | K143176 |
Device Name: | UltraLinq |
Classification | System, Image Processing, Radiological |
Applicant | ULTRALINQ HEALTHCARE SOLUTIONS, INC. 236 West 30th Street, 15th Floor New York, NY 10001 |
Contact | Stephen Farber |
Correspondent | Rita King MethodSense, Inc. PO Box 110352 Durham, NC 27709 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-11-04 |
Decision Date | 2015-07-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00862894000302 | K143176 | 000 |
00862894000319 | K143176 | 000 |