The following data is part of a premarket notification filed by Hamilton Thorne Research with the FDA for Hamilton-thorn Motility Analyzer Htm-2000.
Device ID | K873172 |
510k Number | K873172 |
Device Name: | HAMILTON-THORN MOTILITY ANALYZER HTM-2000 |
Classification | Counter, Cell, Automated (particle Counter) |
Applicant | HAMILTON THORNE RESEARCH 30 A CHERRY HILL DR. Danvers, MA 01923 |
Product Code | GKL |
CFR Regulation Number | 864.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-11 |
Decision Date | 1987-11-06 |