The following data is part of a premarket notification filed by Clarius Mobile Health Corp. with the FDA for Clarius Ultrasound Scanner.
| Device ID | K213436 |
| 510k Number | K213436 |
| Device Name: | Clarius Ultrasound Scanner |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Clarius Mobile Health Corp. 130-2985 Virtual Way Vancouver, CA V5M 4X7 |
| Contact | Agatha Szeliga |
| Correspondent | Agatha Szeliga Clarius Mobile Health Corp. 130-2985 Virtual Way Vancouver, CA V5M 4X7 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-22 |
| Decision Date | 2021-11-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540205001370 | K213436 | 000 |
| 07540205001363 | K213436 | 000 |
| 07540205001325 | K213436 | 000 |
| 07540205001318 | K213436 | 000 |
| 07540205001301 | K213436 | 000 |
| 07540205001295 | K213436 | 000 |
| 07540205001288 | K213436 | 000 |
| 07540205001271 | K213436 | 000 |
| 07540205001189 | K213436 | 000 |