The following data is part of a premarket notification filed by Aco Healthcare Co,. Ltd. with the FDA for Apache Ultrasound System.
| Device ID | K211232 |
| 510k Number | K211232 |
| Device Name: | Apache Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Aco Healthcare Co,. Ltd. Rm. 520, Bldg. 53, No. 195, Sec. 4, Chungshin Rd., Chutung Hsinchu, TW 31057 |
| Contact | Henry Huang |
| Correspondent | Henry Huang Aco Healthcare Co,. Ltd. Rm. 520, Bldg. 53, No. 195, Sec. 4, Chungshin Rd., Chutung Hsinchu, TW 31057 |
| 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 | 2021-04-23 |
| Decision Date | 2021-06-25 |