The following data is part of a premarket notification filed by Teratech Corp. with the FDA for Terason Model 2000/bas Portable Ultrasound System.
| Device ID | K030191 |
| 510k Number | K030191 |
| Device Name: | TERASON MODEL 2000/BAS PORTABLE ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | TERATECH CORP. 77-79 TERRACE HALL AVE. Burlington, MA 01803 |
| Contact | Charles F Hottinger |
| Correspondent | Laura Danielson TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| 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 | Yes |
| Combination Product | No |
| Date Received | 2003-01-21 |
| Decision Date | 2003-01-29 |
| Summary: | summary |