The following data is part of a premarket notification filed by Larsen & Toubro Limited with the FDA for Larsen & Toubro Limited Senorita Color Doppler Ultrasound System.
| Device ID | K040409 |
| 510k Number | K040409 |
| Device Name: | LARSEN & TOUBRO LIMITED SENORITA COLOR DOPPLER ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | LARSEN & TOUBRO LIMITED KIADB INDUSTRIAL AREA HEBBAL, HOTTAGALLI Mysore, Karnataka, IN 570 018 |
| Contact | A.b. Deshpande |
| Correspondent | Juergen Welte TUV RHEINLAND OF NORTH AMERICA, INC. 1279 QUARRY LANE, SUITE A Pleasanton, CA 94566 |
| 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 | 2004-02-18 |
| Decision Date | 2004-02-27 |
| Summary: | summary |