The following data is part of a premarket notification filed by Teca, Inc. with the FDA for Teca Tc2-64 Transcranial Doppler.
Device ID | K850137 |
510k Number | K850137 |
Device Name: | TECA TC2-64 TRANSCRANIAL DOPPLER |
Classification | Flowmeter, Blood, Cardiovascular |
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 | DPW |
CFR Regulation Number | 870.2100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-01-14 |
Decision Date | 1985-08-14 |