The following data is part of a premarket notification filed by Proknow Llc with the FDA for Proknow Ds.
| Device ID | K182855 |
| 510k Number | K182855 |
| Device Name: | ProKnow DS |
| Classification | System, Image Processing, Radiological |
| Applicant | ProKnow LLC 121 Central Park Place Sanford, FL 32771 |
| Contact | Salvadore Gerace |
| Correspondent | Salvadore Gerace ProKnow LLC 121 Central Park Place Sanford, FL 32771 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-10 |
| Decision Date | 2019-01-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860000358705 | K182855 | 000 |
| 07340201500057 | K182855 | 000 |