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 |