The following data is part of a premarket notification filed by Advanced Mechanical Technology, Inc. with the FDA for Biovec Biomechanic Force Analysis System.
Device ID | K883198 |
510k Number | K883198 |
Device Name: | BIOVEC BIOMECHANIC FORCE ANALYSIS SYSTEM |
Classification | Platform, Force-measuring |
Applicant | ADVANCED MECHANICAL TECHNOLOGY, INC. 151 CALIFORNIA ST. Newton, CA 02158 |
Contact | Joseph Gerstann |
Correspondent | Joseph Gerstann ADVANCED MECHANICAL TECHNOLOGY, INC. 151 CALIFORNIA ST. Newton, CA 02158 |
Product Code | KHX |
CFR Regulation Number | 890.1575 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-07-28 |
Decision Date | 1988-10-24 |