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 |