The following data is part of a premarket notification filed by Regulatory Management Services with the FDA for Interson Usb Ultrasound Probe System.
| Device ID | K070907 |
| 510k Number | K070907 |
| Device Name: | INTERSON USB ULTRASOUND PROBE SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | REGULATORY MANAGEMENT SERVICES 16303 PANORAMIC WAY San Leandro, CA 94578 |
| Contact | Gary J Allsebrook |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-04-02 |
| Decision Date | 2007-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857377006100 | K070907 | 000 |