The following data is part of a premarket notification filed by Teca, Inc. with the FDA for Teca Mf-20 Microvascular Doppler.
| Device ID | K850071 |
| 510k Number | K850071 |
| Device Name: | TECA MF-20 MICROVASCULAR DOPPLER |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | TECA, INC. THREE CAMPUS DR. Pleasantiville, NY 10570 |
| Contact | Edward R Sirois |
| Correspondent | Edward R Sirois TECA, INC. THREE CAMPUS DR. Pleasantiville, NY 10570 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-09 |
| Decision Date | 1985-04-02 |