The following data is part of a premarket notification filed by Medline with the FDA for Pureimage Ultrasound Transmission Gel.
| Device ID | K120156 |
| 510k Number | K120156 |
| Device Name: | PUREIMAGE ULTRASOUND TRANSMISSION GEL |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | MEDLINE ONE MEDLINE PLACE Mundlelein, IL 60060 |
| Contact | Matt Clausen |
| Correspondent | Matt Clausen MEDLINE ONE MEDLINE PLACE Mundlelein, IL 60060 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-18 |
| Decision Date | 2012-02-08 |