The following data is part of a premarket notification filed by Kolo Medical (suzhou) Co., Ltd with the FDA for Kolo Evolution Xhd Series Ultrasound Diagnostic System.
| Device ID | K221568 |
| 510k Number | K221568 |
| Device Name: | KOLO Evolution XHD Series Ultrasound Diagnostic System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Kolo Medical (Suzhou) Co., Ltd Room 303-305 And 504, Building A5, No. 218 Xinghu Street Suzhou, CN 215123 |
| Contact | Mike SU |
| Correspondent | Mike SU Kolo Medical (Suzhou) Co., Ltd Room 303-305 And 504, Building A5, No. 218 Xinghu Street Suzhou, CN 215123 |
| 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 | No |
| Combination Product | No |
| Date Received | 2022-05-31 |
| Decision Date | 2022-09-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06975170000119 | K221568 | 000 |
| 06975170000027 | K221568 | 000 |
| 06975170000034 | K221568 | 000 |
| 06975170000041 | K221568 | 000 |
| 06975170000058 | K221568 | 000 |
| 06975170000065 | K221568 | 000 |
| 06975170000072 | K221568 | 000 |
| 06975170000089 | K221568 | 000 |
| 06975170000102 | K221568 | 000 |
| 06975170000010 | K221568 | 000 |