The following data is part of a premarket notification filed by Clarius Mobile Health Corp. with the FDA for Clarius Ultrasound Scanner.
| Device ID | K180799 |
| 510k Number | K180799 |
| Device Name: | Clarius Ultrasound Scanner |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Clarius Mobile Health Corp. 350 - 3605 Gilmore Way Burnaby, CA V5g 4x5 |
| Contact | Brendan Seward |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-03-27 |
| Decision Date | 2018-05-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540205000847 | K180799 | 000 |
| 07540205000861 | K180799 | 000 |