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 |