The following data is part of a premarket notification filed by Interson Corporation with the FDA for Interson Usb Ultrasound System.
| Device ID | K163443 |
| 510k Number | K163443 |
| Device Name: | Interson USB Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Interson Corporation 7150 Koll Center Parkway Pleasanton, CA 94566 |
| Contact | David Asarnow |
| Correspondent | David Asarnow Interson Corporation 7150 Koll Center Parkway Pleasanton, CA 94566 |
| 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 | 2016-12-08 |
| Decision Date | 2017-04-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857356008019 | K163443 | 000 |
| 00857356008002 | K163443 | 000 |