The following data is part of a premarket notification filed by Tetrad Corp. with the FDA for Tetrad Model Tc-c52-, -c84v-, -c95-, -cla76-, -l74-atp Transducers.
Device ID | K014182 |
510k Number | K014182 |
Device Name: | TETRAD MODEL TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP TRANSDUCERS |
Classification | Transducer, Ultrasonic, Diagnostic |
Applicant | TETRAD CORP. 357 INVERNESS DR. SOUTH, SUITE A Englewood, CO 80112 |
Contact | Charles F Hottinger |
Correspondent | Mark Job TUV PRODUCT SERVICE, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
Product Code | ITX |
CFR Regulation Number | 892.1570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2001-12-20 |
Decision Date | 2002-01-03 |
Summary: | summary |