The following data is part of a premarket notification filed by Teratech Corp. with the FDA for Teratech Model 2000 Handheld Ultrasound System With Doppler And Harmonic Imaging Modes.
| Device ID | K012191 |
| 510k Number | K012191 |
| Device Name: | TERATECH MODEL 2000 HANDHELD ULTRASOUND SYSTEM WITH DOPPLER AND HARMONIC IMAGING MODES |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | TERATECH CORP. 19030 PORTOS DR. Saratoga, CA 95070 |
| Contact | Charles F Hottinger |
| Correspondent | Mark Job TUV PRODUCT SERVICE, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-07-13 |
| Decision Date | 2001-07-26 |
| Summary: | summary |