The following data is part of a premarket notification filed by Shantou I Nstitute Of Ultrasonic Instruments (siui with the FDA for Cts-5500/cts-6600 Ultrasonic Pulsed Echo Imaging System.
| Device ID | K061488 |
| 510k Number | K061488 |
| Device Name: | CTS-5500/CTS-6600 ULTRASONIC PULSED ECHO IMAGING SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI 7263 CRONIN CIRCLE Dublin, CA 94568 |
| Contact | Bob Leiker |
| Correspondent | Bob Leiker SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI 7263 CRONIN CIRCLE Dublin, CA 94568 |
| 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 | 2006-05-31 |
| Decision Date | 2006-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06938396466008 | K061488 | 000 |
| 06938396455002 | K061488 | 000 |
| 06938396433017 | K061488 | 000 |