The following data is part of a premarket notification filed by Teratech Corp. with the FDA for Terason Echo T/3000 Ultrasound System With Stress Echo.
| Device ID | K080234 |
| 510k Number | K080234 |
| Device Name: | TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | TERATECH CORP. 77-79 TERRACE HALL AVE. Burlington, MA 01803 |
| 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 | 2008-01-30 |
| Decision Date | 2008-02-14 |
| Summary: | summary |