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 |